Data / Medical devices / Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO): 209 FDA-registered makers in 20 countries

Name: FDA-registered makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

209 establishments in 20 countries are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO, Class 2, 21 CFR 888.3353). 51 of them have a 510(k) clearance or PMA approval on file and 15 have a recall event. The FDA has issued 535 510(k) clearances under this code, the latest on October 1, 2026, and lists 69 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code: LZO
Device class: 2
Regulation: 888.3353
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	110
Germany	12
Italy	12
France	12
China	12
Ireland	11
Switzerland	9
United Kingdom	7
Malaysia	6
Taiwan	3
Japan	3
Australia	2
India	2
Canada	2
South Korea	1
New Zealand	1
San Marino	1
Belgium	1
Netherlands	1
Poland	1

Makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Medacta International SA	Castel San Pietro Ticino, Switzerland	Complaint file establishment, Manufacturer	38	September 17, 2026	0	api.fda.gov
Medacta International SA	Rancate Ticino, Switzerland	Complaint file establishment, Manufacturer	38	September 17, 2026	0	api.fda.gov
Howmedica Osteonics Corp	Mahwah, NJ, United States	Manufacturer, Specification developer	24	April 24, 2024	11	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor	22	May 15, 2025	2	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Contract manufacturer, Manufacturer	19	April 27, 2026	5	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer, Specification developer	19	June 16, 2026	10	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	18	May 19, 2023	7	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	Manufacturer, Specification developer	17	April 24, 2024	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	16	December 8, 2020	8	api.fda.gov
Corin Limited	CIRENCESTER Gloucestershire, United Kingdom	Complaint file establishment, Manufacturer, Specification developer	16	April 7, 2022	1	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer	16	January 6, 2023	1	api.fda.gov
Smith & Nephew Orthopaedics AG	AARAU Aargau, Switzerland	Manufacturer	14	March 28, 2025	1	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	13	July 6, 2026	4	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	12	March 28, 2025	1	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	12	March 28, 2025	0	api.fda.gov
United Orthopedic Corp.	Kaohsiung, Taiwan	Exporter to the US, Manufacturer	11	September 2, 2026	0	api.fda.gov
United Orthopedic Corporation	Hsinchu Hsinchu(County), Taiwan	Exporter to the US, Manufacturer	11	September 2, 2026	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Repackager or relabeler, Specification developer	10	January 6, 2022	0	api.fda.gov
UOC USA Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export	10	January 6, 2025	0	api.fda.gov
implantcast GmbH	Buxtehude Lower Saxony, Germany	Complaint file establishment, Manufacturer	10	March 30, 2026	2	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	9	March 28, 2018	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer, Specification developer	9	May 23, 2025	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Manufacturer, Specification developer	8	May 23, 2025	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	8	March 4, 2025	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	8	July 19, 2021	0	api.fda.gov
Ortho Development Corp.	Draper, UT, United States	Complaint file establishment, Manufacturer, Specification developer	6	September 21, 2011	0	api.fda.gov
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	6	April 10, 2003	0	api.fda.gov
Signature Orthopaedics Pty Limited	Sydney New South Wales, Australia	Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer	6	August 7, 2025	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer, Specification developer	5	February 7, 2025	1	api.fda.gov
Total Joint Orthopedics, Inc.	Salt Lake City, UT, United States	Complaint file establishment, Specification developer	5	September 23, 2022	0	api.fda.gov
B-One Ortho, Corp.	Cedar Knolls, NJ, United States	Manufacturer	4	November 15, 2024	0	api.fda.gov
Serf	DECINES CHARPIEU Rhone, France	Manufacturer, Specification developer	4	December 22, 2023	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	Contract manufacturer, Manufacturer	4	August 7, 2025	0	api.fda.gov
b-ONE Ortho Corp.	Fairfield, NJ, United States	Specification developer	4	November 15, 2024	0	api.fda.gov
Biopro, Inc.	Port Huron, MI, United States	Contract manufacturer, Manufacturer	3	January 18, 1996	1	api.fda.gov
Maxx Orthopedics Inc.	Norristown, PA, United States	Complaint file establishment, Manufacturer, Specification developer	3	January 15, 2026	0	api.fda.gov
Optimized Ortho Pty Ltd	Sydney New South Wales, Australia	Manufacturer	3	August 4, 2020	0	api.fda.gov
Corentec Co., Ltd.	Cheonan Si, Chungnam, South Korea	Exporter to the US, Manufacturer	2	March 16, 2023	0	api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	2	December 8, 2020	0	api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.	SUZHOU Jiangsu, China	Manufacturer	2	August 5, 2021	0	api.fda.gov
Gruppo Bioimpianti S.R.L.	Peschiera Borromeo Milano, Italy	Manufacturer	2	July 22, 2019	0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	Manufacturer	2	February 3, 2011	0	api.fda.gov
KYOCERA Medical Corporation	Kyoto, Japan	Complaint file establishment, Specification developer	2	December 5, 2024	0	api.fda.gov
KYOCERA Medical Corporation Shiga Higashiomi Plant	Higashiomi-shi Shiga, Japan	Contract manufacturer, Manufacturer	2	December 5, 2024	0	api.fda.gov
KYOCERA Medical Corporation Shiga Yasu Plant	Yasu-shi Shiga, Japan	Contract manufacturer, Manufacturer	2	December 5, 2024	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	2	April 11, 2011	1	api.fda.gov
Biomet Uk Ltd.	Bridgend, United Kingdom	Specification developer	1	July 29, 2020	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	1	March 1, 2013	0	api.fda.gov
Meril Healthcare Pvt. Ltd.	Vapi Gujarat, India	Manufacturer	1	July 18, 2019	0	api.fda.gov
Xerxes Arthropedix	Naples, FL, United States	Specification developer	1	June 15, 2023	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer, Manufacturer	1	December 8, 2006	0	api.fda.gov
3D Instrumentation Sdn Bhd	Bukit Mertajam Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Abbott Laboratories	Irving, TX, United States	Specification developer	0		0	api.fda.gov
Accentus Medical Ltd	DIDCOT Oxfordshire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Adler Ortho S.P.A.	Cormano Milano, Italy	Manufacturer	0		0	api.fda.gov
Akshar Gamma Steriles LLP	THANE Maharashtra, India	Contract manufacturer	0		0	api.fda.gov
Almark Tool & Manufacturing Company, Inc.	Garwood, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Aps Materials Inc. Ireland	Waterford Waterford(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
APS Materials Suzhou	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	api.fda.gov
Aristotech Industries GMBH	Luckenwalde Brandenburg, Germany	Contract manufacturer	0		0	api.fda.gov
Armbruster GMBH	Steinach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Adler Ortho SpA	Mezzolombardo Trento, Italy	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Additive / Slice Manufacturing Studios	Akron, OH, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
B & G MFG. Co.	Hatfield, PA, United States	Contract manufacturer	0		0	api.fda.gov
B-One Medical (suzhou) Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
Biomet France	Valence Drome, France	Manufacturer	0		0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Caragh Precision	Galway Galway(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	api.fda.gov
CERAMTEC GmbH Medical Products Division	MARKTREDWITZ Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
CERAMTEC GmbH Medical Products Division	PLOCHINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Charles Pery & Cie	SCIONZIER Haute-Savoie, France	Contract manufacturer	0		0	api.fda.gov
CPM Medical Consultants, LLC.	Farmers Branch, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	api.fda.gov
ConforMIS, Inc.	Wilmington, MA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Dot America, Inc.	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Dot GMBH	Rostock Mecklenburg-Western Pomerania, Germany	Contract manufacturer	0		0	api.fda.gov
Eddi Bressan S.R.L.	CORMONS Gorizia, Italy	Contract manufacturer	0		0	api.fda.gov
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Oakland, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Flex-Cell Precision, Inc.	Lancaster, PA, United States	Contract manufacturer	0		0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	api.fda.gov
Ferry Machine Corporation	Little Ferry, NJ, United States	Contract manufacturer	0		0	api.fda.gov
GB Implantat Technologie GMBH	Bochum North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Hammill MFG. Co.	Maumee, OH, United States	Contract manufacturer	0		0	api.fda.gov
Harwood Design, Inc.	Bristol, PA, United States	Contract manufacturer	0		0	api.fda.gov
HPF S.R.L.	Forgaria nel Friuli Friuli Venezia Giulia, Italy	Contract manufacturer	0		0	api.fda.gov
Himed, LLC	Old Bethpage, NY, United States	Contract manufacturer	0		0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Implants Intl. Ltd.	THORNABY-ON-TEES Stockton-on-Tees, United Kingdom	Manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	api.fda.gov
Innotool&greminger AG	Erlen Thurgau, Switzerland	Contract manufacturer	0		0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Ken-Mar Machine MFG Corp	Paterson, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Kyocera Medical Technologies, Inc.	Redlands, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek (wuxi) Co., Ltd.	Wuxi Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Lincotek Bologna S.R.L.	Cadriano di Granarolo, Bologna, Italy	Contract manufacturer	0		0	api.fda.gov
Lincotek Trento S.P.A	Cire di Pergine Trento, Italy	Contract manufacturer	0		0	api.fda.gov
LSM-MED S.r.l.	Serravalle San Marino Citta, San Marino	Contract manufacturer	0		0	api.fda.gov
Limacorporate S.p.A.	Calatafimi Segesta (TP) Sicilia, Italy	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	api.fda.gov
Mack Molding Company	Arlington, VT, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	api.fda.gov
Marle Finishing SAS	La Talaudiere Loire, France	Contract manufacturer	0		0	api.fda.gov
Materialise N.V.	LEUVEN Vlaams Brabant, Belgium	Manufacturer	0		0	api.fda.gov
Medical Conteneur SAS	SAINT-SOUPPLETS Seine-et-Marne, France	Contract manufacturer	0		0	api.fda.gov
Medical Group	SAINT-PRIEST Auvergne-Rhone-Alpes, France	Contract manufacturer	0		0	api.fda.gov
Medicoat SAS	ETUPES Bourgogne-Franche-Comte, France	Contract manufacturer	0		0	api.fda.gov
Meprotech	Heerhugowaard Noord-Holland, Netherlands	Contract manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Mid South Precision	Murfreesboro, TN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
Materialise USA, LLC.	Plymouth, MI, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Mathys AG Bettlach	Bettlach Solothurn, Switzerland	Contract manufacturer	0		0	api.fda.gov
Mathys Orthopaedie GmbH	Moersdorf Thuringia, Germany	Contract manufacturer	0		0	api.fda.gov
Mendell	Lakeville, MN, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
MicroPort Orthopedics Global Supply Center Limited	Shanghai, China	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Novosource, LLC	Morgantown, WV, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Oberg Medical Products Company	Sarver, PA, United States	Contract manufacturer	0		0	api.fda.gov
Oeb S.R.L.	Camposanto Modena, Italy	Contract manufacturer	0		0	api.fda.gov
Onkos Surgical, Inc.	Parsippany, NJ, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedics-Chelsea	Chelsea, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Orthoplastics Ltd	Bacup Lancashire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.	Waterville Quebec, Canada	Contract manufacturer	0		0	api.fda.gov
Precera Medical Herouville SAS	HEROUVILLE ST CLAIR CEDEX Normandie, France	Contract manufacturer	0		0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	api.fda.gov
PRO-TECH Design & Mfg, Inc.	Arlington, TX, United States	Contract manufacturer	0		0	api.fda.gov
Puracon GMBH	Rosenheim Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Phillips Precision Inc	Elmwood Park, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Polymer Corporation	Middletown, CT, United States	Contract manufacturer	0		0	api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
Samaplast AG	Sankt Margrethen Sankt Gallen, Switzerland	Contract manufacturer	0		0	api.fda.gov
SAS Etablissements Maurice Marle	NOGENT Haute-Marne, France	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Sferic	MENARS Centre-Val de Loire, France	Contract manufacturer	0		0	api.fda.gov
Sheffield Precision Medical Ltd	Sheffield, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smithstown Light Engineering	Shannon Clare, Ireland	Contract manufacturer	0		0	api.fda.gov
Sti Lualdi S.R.L.	Casiacco Pordenone, Italy	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Surgtech, Inc.	Westlake, OH, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Symmetry Medical Ireland Limited	Midleton, Cork Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Lansing, MI, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
Syntec Scientific Corp.	CHANG HUA Changhua, Taiwan	Contract manufacturer	0		0	api.fda.gov
Smith and Nephew Operations Sdn. Bhd	Penang Pulau Pinang, Malaysia	Manufacturer	0		0	api.fda.gov
Stryker (Suzhou) Medical Technology Co.,Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	Contract manufacturer	0		0	api.fda.gov
Stryker Poland Manufacturing Sp. z o.o.	Skawina Malopolskie, Poland	Contract manufacturer	0		0	api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)	Bayan Lepas Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Trigon Incorporated	Mc Murray, PA, United States	Contract manufacturer	0		0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	api.fda.gov
Valtecne SPA	Berbenno di Valtellina Sondrio, Italy	Contract manufacturer	0		0	api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)	Parkrose, OR, United States	Contract manufacturer	0		0	api.fda.gov
Vaupell Midwest Molding and Tooling	Constantine, MI, United States	Contract manufacturer	0		0	api.fda.gov
Viant AS&O Holdings, LLC	Brimfield, MA, United States	Contract manufacturer	0		0	api.fda.gov
Viant Chaumont S.A.S.	CHAUMONT Haute-Marne, France	Contract manufacturer	0		0	api.fda.gov
Westlake Plastics Europe	TOURCOING Nord, France	Contract manufacturer	0		0	api.fda.gov
Windsor Beach Technologies, Inc.	Fairview, PA, United States	Contract manufacturer	0		0	api.fda.gov
Xian Airfoil Technology Co., Ltd.	Xian Shaanxi, China	Contract manufacturer	0		0	api.fda.gov
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer	0		0	api.fda.gov
Zimmer Manufacturing B.V.	Mercedita, PR, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	Contract manufacturer	0		0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Contract manufacturer	0		0	api.fda.gov
b-ONE Medical (Beijing) Co., Ltd.	Beijing, China	Contract manufacturer	0		0	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		0	api.fda.gov

Updated October 1, 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.