Data / Medical devices / United States / Globus Medical, Inc.
Globus Medical, Inc.: FDA-registered device maker in Audubon, PA, United States, 201 510(k) clearances and 1 PMA approval
Globus Medical, Inc. is registered with the FDA (registration 3004142400) in Audubon, PA, United States. It lists 86 device types. The FDA files 201 510(k) clearances and 1 PMA approval under its listings, the newest dated August 4, 2026. 15 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004142400
- Address
- 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER, Audubon, PA, United States, 19403
- Owner or operator
- GLOBUS MEDICAL, INC. (9056090)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- August 19, 2003
- Registered through
- 2026
- Brand names listed
- ACTIFY 3D, ACTIFY Uni, ADIRA, AERIAL, AFFIRM VCF, ALTERA, ALVUE, ANTHEM 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. Newest 100 of 201.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2026 | K254043 | TRIVANCE Hip Stem | LPH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 31, 2026 | K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert) | JWH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 18, 2026 | K261651 | Precice Max System and Precice Ankle Salvage System | HSB | Substantially Equivalent | NuVasive Specialized Orthopedics | accessdata.fda.gov |
| May 7, 2026 | K253739 | SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 29, 2026 | K253401 | SCRIPT Implant System | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 24, 2026 | K261043 | AUTOBAHN Nailing System | HSB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| February 26, 2026 | K252166 | RIB LINK Fixation System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 22, 2025 | K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | OVE | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| November 5, 2025 | K250599 | ExcelsiusGPS Instruments | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 18, 2025 | K251161 | ANTHEM® Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 8, 2025 | K241525 | ExcelsiusXR | SBF | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 6, 2025 | K243456 | ONVOY Acetabular System | LPH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 20, 2024 | K243671 | ExcelsiusGPS® Instruments | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 6, 2024 | K241260 | ACTIFY Unicondylar Knee System | HSX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 6, 2024 | K234035 | COSINE Spacer | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 20, 2024 | K240669 | ACTIFY 3D Total Knee System, ACTIFY Total Knee System | JWH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 14, 2024 | K240721 | ExcelsiusFlex | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 3, 2024 | K240947 | TENSOR® Suture Button System | HTN | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 29, 2024 | K240568 | DuraPro Oscillating System | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 14, 2024 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | NKG | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| February 9, 2024 | K233638 | VERZA High Speed Drills | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 25, 2024 | K233735 | ADIRA Lateral Plate System | KWQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 31, 2023 | K232318 | VICTORY Lumbar Plate System | KWQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 4, 2023 | K231333 | STRETTO Cable System | JDQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 20, 2023 | K230565 | HILINE Fixation System | OWI | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 12, 2023 | K223731 | NuVasive Modulus-C Interbody System | ODP | Substantially Equivalent | Nuvasive, Inc. | accessdata.fda.gov |
| December 19, 2022 | K213196 | MARVEL Growing Rods | PGM | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 21, 2022 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 3, 2022 | K213842 | ONVOY Acetabular System | LPH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 9, 2022 | K220659 | AUTOBAHN(R) EVO Femoral Nails | HSB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 8, 2022 | K222409 | CAPTIVATE® Compression Screws | HWC | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 11, 2022 | K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | FMF | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 26, 2022 | K213591 | ANTHEM® Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 1, 2021 | K212433 | Anthem Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 18, 2021 | K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | NKG | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 19, 2021 | K203153 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 29, 2020 | K202496 | ANTHEM Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 31, 2020 | K201087 | CORBEL Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 14, 2020 | K192115 | SABLE Expandable Spacer | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 16, 2019 | K192744 | CORRIDOR Fixation System | MRW | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 23, 2019 | K192314 | RESONATE Anterior Cervical Plate System | KWQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 18, 2019 | K191391 | HEDRON Lumbar Spacers | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 17, 2019 | K191243 | HEDRON Cervical Spacers | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 6, 2019 | K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 8, 2019 | K190147 | COLOSSEUM Mesh | MQP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 19, 2019 | K183056 | ASSURE® Anterior Cervical Plate System | KWQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 9, 2019 | K190653 | ExcelsiusGPS | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 8, 2019 | K182375 | CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 5, 2019 | K190598 | CROSSWAY Spinal Access System | HRX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 8, 2019 | K190276 | Provident II Hip Stem | LPH | Substantially Equivalent | Stelkast, Inc. | accessdata.fda.gov |
| February 6, 2019 | K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | OUR | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 18, 2018 | K180909 | REVEL Spacers | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 6, 2018 | K181357 | PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 22, 2018 | K180554 | ANTHEM Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 19, 2018 | K173982 | FORTIFY Corpectomy Spacers | MQP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 25, 2018 | K180690 | Navigation Instruments | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 23, 2018 | K173722 | PATRIOT COLONIAL Spacer, SUSTAIN Spacer | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 21, 2018 | K180817 | AERIAL Interspinous Fixation | PEK | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 2, 2018 | K180210 | CREO® Stabilization System | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 27, 2018 | K172269 | FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System | PML | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 7, 2018 | K171939 | ALVUE Balloon Dilation System | GCJ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 19, 2018 | K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | JWH | Substantially Equivalent | Stelkast, Inc. | accessdata.fda.gov |
| January 12, 2018 | K172438 | ARBOR External Fixation System | KTT | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 29, 2017 | K171108 | AUTOBAHN Nailing System | HSB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 20, 2017 | K173115 | COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| November 13, 2017 | K173166 | ANTHEM Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| November 9, 2017 | K162315 | FORTIFY Corpectomy Spacers | MQP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| October 26, 2017 | K172417 | SILC® Fixation System | OWI | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 25, 2017 | K170157 | INDEPENDENCE® Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 14, 2017 | K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System | NQW | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 1, 2017 | K162825 | CAPTIVATE Compression Screws | HWC | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 7, 2017 | K163361 | ANTHEM Fracture System | HRS | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 23, 2017 | K162618 | CONCORD Plus Radiopaque Bone Cement | NDN | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 29, 2016 | K161379 | ELSA Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 21, 2016 | K161591 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | NKG | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| September 7, 2016 | K162222 | GENflex2 Total Knee System | JWH | Substantially Equivalent | Stelkast, Inc. | accessdata.fda.gov |
| August 29, 2016 | K160597 | INDEPENDENCE MIS Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 15, 2016 | K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| April 13, 2016 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 16, 2016 | K151665 | SUSTAIN Additional Implants | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| February 3, 2016 | K153203 | Navigation Instruments | OLO | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 29, 2016 | K151939 | COALITION Spacers | OVE | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| June 4, 2015 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | NKG | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 31, 2015 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | ODP | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| February 26, 2015 | K142498 | MAGNIFY and MAGNIFY-S Spacers | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| January 30, 2015 | K143633 | CREO Stabilization System | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 26, 2014 | K133678 | CONFIRM BIOACTIVE | MQV | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 1, 2014 | K140411 | ALTERA SPACER | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 21, 2014 | K133482 | SILC FIXATION SYSTEM | OWI | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| March 11, 2014 | K133350 | REVERE STABILIZATION SYSTEM | NKB | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| February 20, 2014 | K133567 | UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 30, 2013 | K132559 | MONUMENT SPACERS | OVD | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| December 24, 2013 | K130977 | SIGNIFY BIOACTIVE | MQV | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| November 22, 2013 | K132191 | SP-FIX SPINOUS PROCESS FIXATION PLATE | PEK | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 15, 2013 | K130392 | KINEX BIOACTIVE | MQV | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| August 5, 2013 | K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Stelkast Company | accessdata.fda.gov |
| July 30, 2013 | K131449 | COALITION SPACER | OVE | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| July 26, 2013 | K130478 | SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 13, 2013 | K124058 | CREO STABILIZATION SYSTEM | OSH | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
| May 13, 2013 | K123913 | LATIS SPACER | MAX | Substantially Equivalent | Globus Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 28, 2012 | P100003 | SECURE-C ARTIFICIAL CERVICAL DISC | MJO | 8 | June 12, 2023 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 3, 2025 | 96615 | Class II | Ongoing | MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S | Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm. | accessdata.fda.gov |
| December 15, 2023 | 93804 | Class II | Ongoing | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 | Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination. | accessdata.fda.gov |
| December 11, 2023 | 93742 | Class II | Ongoing | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. | accessdata.fda.gov |
| December 7, 2023 | 93647 | Class I | Ongoing | ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement. | accessdata.fda.gov |
| July 22, 2020 | 86164 | Class II | Terminated | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) | Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. | accessdata.fda.gov |
| December 1, 2014 | 70082 | Class II | Terminated | EXp Tibial Insert; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerativ | Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult. | accessdata.fda.gov |
| August 28, 2013 | 66266 | Class II | Terminated | Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filler | The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured. | accessdata.fda.gov |
| June 24, 2013 | 65823 | Class II | Terminated | SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions. | The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw. | accessdata.fda.gov |
| January 24, 2013 | 64505 | Class II | Terminated | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. | accessdata.fda.gov |
| May 5, 2009 | 53772 | Not yet classified | Terminated | Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedur | incorrect size markings on component | accessdata.fda.gov |
| October 31, 2008 | 50520 | Not yet classified | Terminated | Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from | A possible breach of the sterile barrier packaging (Tyvek pouch). | accessdata.fda.gov |
| October 7, 2008 | 50128 | Not yet classified | Terminated | Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439 | Sterility may be compromised due to breach in packaging. | accessdata.fda.gov |
| September 3, 2008 | 49564 | Not yet classified | Terminated | Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial | Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number. | accessdata.fda.gov |
| October 5, 2007 | 45528 | Not yet classified | Terminated | StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317 | The screws may fracture | accessdata.fda.gov |
| September 24, 2004 | 30287 | Not yet classified | Terminated | Proven Porous CR Femur. Implantable orthopedic device | Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch | accessdata.fda.gov |
Compare with other makers
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- All makers of Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
Updated August 4, 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.