FDA Device recall Z-1055-2018
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM P…
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM P… by Zimmer Biomet, citing the LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant af….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1055-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-29 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " 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
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Identifiers
| code_info | 00-5790-020-00 00-5790-021-00 00-5790-022-00 00-5790-023-00 00-5790-024-00 00-5790-025-00 00-5790-026-00 00-5790…00-5790-020-00 00-5790-021-00 00-5790-022-00 00-5790-023-00 00-5790-024-00 00-5790-025-00 00-5790-026-00 00-5790-027-00 00-5790-028-00 00-5790-029-00 00-5790-030-00 00-5790-031-00 00-5790-020-00 61855504 00-5790-020-00 11004267 00-5790-020-00 61933229 00-5790-020-00 61915949 00-5790-020-00 11005144 00-5790-020-00 61949771 00-5790-020-00 62062057 00-5790-020-00 77001776 00-5790-022-00 61788933 00-5790-022-00 61810168 00-5790-022-00 61831670 00-5790-022-00 61894364 00-5790-022-00 11004689 00-5790-022-00 61910487 00-5790-022-00 61932359 00-5790-022-00 11004850 00-5790-022-00 61939861 00-5790-022-00 61958404 00-5790-022-00 61993535 00-5790-022-00 61987879 00-5790-022-00 62041075 00-5790-022-00 62074833 00-5790-022-00 11006797 00-5790-022-00 77001778 00-5790-024-00 61788934 00-5790-024-00 61805631 00-5790-024-00 61822278 00-5790-024-00 61928510 00-5790-024-00 61952565 00-5790-024-00 62025572 00-5790-024-00 62054459 00-5790-024-00 62068114 00-579 |
|---|
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-1055-2018%22
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