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RECAP HIP SYSTEM

Biomet Orthopedics, LLC · Model US157252 · UDI-DI 00880304684331

KXA Prescription
1
510(k) clearances
12,332
Adverse events (40 deaths)
16
Recalls
27
Facilities

Recalls

DateFirmReason
2012-09-04Zimmer, Inc.Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiv
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub
2010-08-23Depuy Orthopaedics, Inc.As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, pub

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.