FDA Device recall Z-0836-2016
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are i…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are i… by Zimmer Biomet, citing LDPE bag containing the implant adheres to the highly polished implant surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0836-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."
Reason
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-…Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-014-01 00-5842-014-02 00-5842-015-01 00-5842-015-02 00-5842-016-01 00-5842-016-02 00-5842-017-01 00-5842-017-02 Lot numbers: 11002504 11002764 11002766 11002767 11002780 11002782 11002784 11003009 11003028 11003042 11003048 11003345 11003366 11003367 11003370 11003371 11003384 11003398 11003399 11003413 11003414 11003433 11003452 11003488 11003490 11003491 11003584 11003587 11003588 11003589 11003603 11003611 11003635 11003642 11003649 11003658 11003659 11003660 11003661 11003689 11003855 11003868 11003878 11003904 11003921 11003944 11003959 11003960 11003974 11004052 11004056 11004074 11004146 11004150 11004152 11004161 11004204 11004306 11004335 11004401 11004402 11004408 11004446 11004450 11004451 11004452 11004455 11004463 11004553 11004563 11004564 11004626 11004677 11004707 11004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2016%22
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