Data / Medical devices / United States / Tornier, Inc.
Tornier, Inc.: FDA-registered device maker in Bloomington, MN, United States, 65 510(k) clearances
Tornier, Inc. is registered with the FDA (registration 1649390) in Bloomington, MN, United States. It lists 63 device types. The FDA files 65 510(k) clearances under its listings, the newest dated July 22, 2026. 32 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1649390
- FEI number
- 3000718467
- Address
- 10801 Nesbitt Avenue South, Bloomington, MN, United States, 55437
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- June 9, 1986
- Registered through
- 2027
- Brand names listed
- 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10mm SUBFIX TRIAL, 11.5MM FLEXIBLE REAMER, 11.5mm SUBFIX TRIAL, 11MM FLEXIBLE REAMER, 12MM FLEXIBLE REAMER, 135 mm Reusable Slat, SE Retr, 10 Pack and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | K260721 | Tornier Perform Advanced Glenoid | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 12, 2026 | K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System | PHX | Substantially Equivalent | Stryker Corporation (Tornier, Inc.) | accessdata.fda.gov |
| January 8, 2026 | K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 30, 2025 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | KWT | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 6, 2024 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | KWS | Substantially Equivalent | Stryker Corporation (Tornier, Inc.) | accessdata.fda.gov |
| February 21, 2024 | K232265 | BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier S.A.S. | accessdata.fda.gov |
| October 31, 2023 | K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | HSB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 14, 2022 | K220914 | Tornier Perform Humeral System Fracture | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 14, 2022 | K220418 | Tornier Perform Humeral System Stemless | PKC | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| November 12, 2021 | K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 26, 2021 | K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 11, 2020 | K201315 | PERFORM Humeral System Stem | PAO | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 5, 2020 | K193247 | LATITUDE EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| July 17, 2019 | K191711 | ORTHOLOC SPS Shoulder Plating System | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 14, 2019 | K191318 | AEQUALIS FLEX REVIVE Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| January 30, 2019 | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 27, 2018 | K182461 | LATITUDE EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| October 5, 2018 | K181587 | ORTHOLOC SPS Shoulder Plating System | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 20, 2018 | K181420 | Aequalis Flex Revive Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 31, 2017 | K171010 | Latitude EV Total Elbow Arthroplasty | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| November 15, 2016 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 10, 2016 | K160975 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 23, 2015 | K150583 | Aequalis PerFORM+ Shoulder System | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143552 | Simpliciti Shoulder System | PKC | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| August 21, 2014 | K142148 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| August 21, 2014 | K141004 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| July 11, 2014 | K141301 | MAXLOCK EXTREME ELBOW FRACTURE SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 18, 2014 | K141029 | TORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 4, 2014 | K133777 | TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| January 3, 2014 | K132733 | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES | HTN | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| December 5, 2013 | K133376 | AEQUALIS HUMERAL NAIL; SIZES 7MM & 8MM X 210, 230, 250, 270MM; LEFT AND RIGHT | HSB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 19, 2013 | K132632 | TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 17, 2013 | K132591 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| August 15, 2013 | K130832 | ORTHOHELIX STAPLE SYSTEM | JDR | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 31, 2013 | K131324 | MAXTORQUE SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 13, 2013 | K122635 | TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR | MAI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 4, 2013 | K130422 | PHANTOM FIBER BIOFIBER SUTURE | NWJ | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| December 14, 2012 | K123203 | MAXLOCK EXTREME SYSTEM MODEL MXL | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| September 6, 2012 | K122005 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| July 5, 2012 | K120739 | AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 13, 2012 | K121437 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| April 17, 2012 | K120165 | INTRAOSSEOUS FIXATION SYSTEM | HTY | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| April 10, 2012 | K120157 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| January 30, 2012 | K113048 | MAXLOCK EXTREME SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| January 25, 2012 | K111337 | TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD | FTL | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 6, 2011 | K111041 | MINI VARIABLE SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 2, 2011 | K110773 | TORNIER INSITE FT SUTURE ANCHOR | MBI | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 27, 2010 | K101962 | MINI MAXLOCK EXTREME PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| June 29, 2010 | K100562 | LATITUDE ELBOW PROSTHESIS | JDB | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| April 20, 2010 | K100618 | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| September 21, 2009 | K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | MBI | Substantially Equivalent | Tornier | accessdata.fda.gov |
| July 2, 2009 | K090582 | CALCANEAL FRACTURE PLATE SYSTEM | HRS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| June 15, 2009 | K090289 | CLAVICLE PLATING SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| January 27, 2009 | K082754 | AEQUALIS HUMERAL NAIL SYSTEM | HSB | Substantially Equivalent | Tornier | accessdata.fda.gov |
| December 8, 2008 | K082574 | MAXTORQUE MINI CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| March 20, 2008 | K073624 | MODULAR FOOT SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| August 24, 2007 | K070787 | LATITUDE ELBOW PROTHESIS | JDB | Substantially Equivalent | Tornier | accessdata.fda.gov |
| June 29, 2006 | K061400 | CALCANEAL TRAUMA SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| May 10, 2006 | K060386 | NEXA CARPO METACARPAL IMPLANT | KYI | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| March 7, 2006 | K060428 | CSS CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| February 27, 2006 | K053182 | DRLOCK DISTAL RADIUS VOLAR SYSTEM | HRS | Substantially Equivalent | Orthohelix Surgical Designs, Inc. | accessdata.fda.gov |
| December 22, 2005 | K053408 | NEXA BONE PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Nexa Orthopedics, Inc. | accessdata.fda.gov |
| September 6, 2002 | K022726 | STAYFUSE GT-IP | HWC | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| April 29, 1999 | K990804 | STAYFUSE | HWC | Substantially Equivalent | Pioneer Surgical Technology | accessdata.fda.gov |
| December 9, 1997 | K973453 | TORNIER CEMENT RESTRICTOR | JDI | Substantially Equivalent | Tornier | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | 98512 | Class II | Ongoing | Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252 | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. | accessdata.fda.gov |
| December 19, 2025 | 98123 | Class II | Ongoing | TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery. | accessdata.fda.gov |
| March 3, 2025 | 96494 | Class II | Ongoing | stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct) | accessdata.fda.gov |
| August 29, 2024 | 95258 | Class II | Ongoing | stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder | One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device). | accessdata.fda.gov |
| August 29, 2024 | 95245 | Class II | Ongoing | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty | Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer. | accessdata.fda.gov |
| January 3, 2024 | 93709 | Class II | Ongoing | Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile. | The incorrect device is contained in the labeled package. | accessdata.fda.gov |
| September 15, 2023 | 93051 | Class II | Ongoing | stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. | accessdata.fda.gov |
| June 12, 2023 | 92520 | Class II | Ongoing | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa. | accessdata.fda.gov |
| May 3, 2022 | 90052 | Class II | Ongoing | Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit | The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. | accessdata.fda.gov |
| May 28, 2021 | 88004 | Class II | Terminated | Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component. | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. | accessdata.fda.gov |
| October 18, 2019 | 84033 | Class II | Terminated | Aequalis Ascend Flex Humeral Stem: Part Number UDI DWF601A 3700386944475 DWF601B 3700386944482 DWF601C 3700386944499 DWF602A 3700386944505 DWF602B 3700386944512 DWF602C 3700386944529 DWF603A 3700386944536 DWF603B 3700386 | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem. | accessdata.fda.gov |
| March 26, 2018 | 79907 | Class II | Terminated | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types o | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | accessdata.fda.gov |
| February 8, 2018 | 79373 | Class II | Terminated | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected. | accessdata.fda.gov |
| September 19, 2016 | 75444 | Class II | Terminated | Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part | Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem. | accessdata.fda.gov |
| August 6, 2015 | 71913 | Class II | Terminated | Salto Talaris Tibial Guide, Part # MJU333,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument | Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide. | accessdata.fda.gov |
| June 25, 2015 | 71605 | Class II | Terminated | Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument. | Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the ability to fixate Aequalis IM Nail screws. | accessdata.fda.gov |
| September 19, 2014 | 69294 | Class II | Terminated | MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area. | Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer | accessdata.fda.gov |
| August 13, 2013 | 66057 | Class II | Terminated | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. Th | Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument | accessdata.fda.gov |
| October 30, 2012 | 64485 | Class II | Terminated | Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures. | The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire. | accessdata.fda.gov |
| August 22, 2011 | 60454 | Not yet classified | Terminated | MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small | The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing. | accessdata.fda.gov |
| July 6, 2011 | 59462 | Not yet classified | Terminated | Mini MaxLock Extreme Plating System Case & Tray, Model Number(s): MXM-901, Product Usage: The Mini MaxLock Extreme Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for | The surgical tray does not meet our Instruction for Use (IFU) for dry time requirement. | accessdata.fda.gov |
| June 23, 2011 | 59399 | Not yet classified | Terminated | Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total el | Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. | accessdata.fda.gov |
| October 15, 2010 | 57095 | Not yet classified | Terminated | CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031 | The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) | accessdata.fda.gov |
| March 23, 2010 | 55256 | Not yet classified | Terminated | Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear t | On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081. | accessdata.fda.gov |
| January 29, 2010 | 54725 | Class II | Terminated | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of | The tips of the drivers are breaking while being used to drive the screws into patients. | accessdata.fda.gov |
| October 16, 2009 | 54542 | Not yet classified | Terminated | Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, | The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument. Also the adapters have a wobble between the two ends. This is caused when the distal and pro | accessdata.fda.gov |
| September 3, 2009 | 54541 | Not yet classified | Terminated | Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws | The epoxy is flaking off the drill bits and countersinks. | accessdata.fda.gov |
| April 7, 2009 | 54540 | Not yet classified | Terminated | MaxTorque Cannulated Screw Model # MSD-010-55-060S | A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw. | accessdata.fda.gov |
| September 27, 2007 | 44963 | Not yet classified | Terminated | Axya Bone Anchor, 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Axya Medical, Inc., Beverly, MA 01915 | Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging | accessdata.fda.gov |
| September 4, 2007 | 44883 | Not yet classified | Terminated | DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R, Fixed Short Right Plate, DRV-002-1L, Fixed Stand | Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened. | accessdata.fda.gov |
| August 3, 2006 | 36843 | Not yet classified | Terminated | DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right le | The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized. | accessdata.fda.gov |
| November 1, 2005 | 34498 | Not yet classified | Terminated | MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System. | Screwdriver pilot taper tip can break during surgery. | accessdata.fda.gov |
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Updated July 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.