3DKnee e+ Tibial Insert — Class II medical device recall Z-1213-2013
Terminated recall by Encore Medical, Lp, reported 2013-05-08, distributed in CA. U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packa
| Recall number | Z-1213-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2013-04-01 |
| Classified | 2013-05-02 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2013-07-01 |
| Distributed | CA |
| Countries outside the US | VE |
| Quantity | 5 |
| Reason classes | labeling |
| Serial numbers | 59602230 |
| Model numbers | 391-15-708 |
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Reason for recall
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
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-1213-2013. 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.