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B-P TOTAL HIP SYSTEM

ENDOTEC, INC. · Model 01-03-0032 · UDI-DI 00814193022981

KXA Prescription

510(k) clearances

12,510

Adverse events (40 deaths)

Recalls

Facilities

Description

B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 32.5 MM

Recalls

Date	Firm	Reason
2012-09-04	Zimmer, 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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
2010-08-23	Depuy 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.