Recall Z-0527-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0527-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-08-21, terminated 2021-07-21. It names 3 FDA 510(k) clearances: K051843, K010827, K010635. Product: Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.. Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Terminated: 2021-07-21
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

3 on FDA's record

K051843 — COPELAND EAS HUMERAL RESURFACING HEADSBiomet, Inc.·cleared 2005-09-29
K010827 — COPELAND MB/HA RESURFACING HUMERAL HEADSBiomet Orthopedics, Inc.·cleared 2001-09-14
K010635 — INTERLOK / HA COPELAND RESURFACING HEADSBiomet, Inc.·cleared 2001-08-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

Reason for recall

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.