FDA Device recall Z-0837-2016
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer variou…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer variou… 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-0837-2016 |
| 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
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only."
Reason
LDPE bag containing the implant adheres to the highly polished implant surface.
Identifiers
| code_info | Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-…Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-014-01 00-5926-014-02 00-5926-015-01 00-5926-015-02 Lot numbers: 11003385 11003487 11003827 11003957 11004055 11004100 11004102 11004106 11004145 11004378 11004444 11004449 11004454 11004464 11004499 11005712 11005779 11005783 11006058 11006623 11006851 11006878 11006925 11006973 11008245 11008259 11008270 11008331 11008381 61771793 61771795 61777453 61777454 61777455 61777456 61777457 61782636 61782637 61782638 61782639 61782640 61782641 61782642 61788821 61788822 61788823 61788824 61788825 61788826 61788827 61795693 61795694 61795695 61795696 61795697 61795698 61801039 61801040 61801041 61801042 61801043 61801044 61805590 61805591 61805592 61805593 61805594 61805595 61809895 61809897 61809898 61809899 61809901 61809902 61815366 61815367 61815368 61815369 61815370 61815371 61822252 |
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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-0837-2016%22
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