Natural Knee II Revision Femoral Stem — Class II medical device recall Z-1948-2015
Terminated recall by Zimmer, Inc., reported 2015-07-08, distributed nationwide. Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If
| Recall number | Z-1948-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-10-02 |
| Classified | 2015-07-01 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-07-01 |
| Distributed | Nationwide (US) |
| Quantity | 352 |
| Reason classes | sterility |
| Lot numbers | 11011448, 11012660, 60394169, 60415420, 60515793, 60564530, 60601129, 60614014, 60797044, 60803056, 60841848, 60922655, 60922656, 60927853, 60989112, 61017152, 61104192, 61135872, 61200531, 61284571, 61366919, 61464308, 61505310, 61533025, 61566733, 61742151, 61780361, 61784264, 61834192, 61834778, 61840307, 61930376, 61947884, 61947885, 62097910, 62146925, 62195165, 62249431, 62281270, 62305675 and 23 more |
| Model numbers | 11011448, 11012660, 60394169, 60415420, 60515793, 60564530, 60601129, 60614014, 60797044, 60803056, 60841848, 60922655, 60922656, 60927853, 60989112, 61017152, 61104192, 61135872, 61200531, 61284571, 61366919, 61464308, 61505310, 61533025, 61566733 and 39 more |
Product
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Reason for recall
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
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-1948-2015. 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.