FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+… — Class II medical device recall Z-1055-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-03-21, distributed nationwide. The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished sur
| Recall number | Z-1055-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BO, BR, CA, CL, CN, CO, EC, IN, JP, KR, MX, MY, NI, NL, NZ, PA, SG, SV, TH, TW |
| Quantity | 13,227 in |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1055-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.