FDA Device recall Z-1213-2013
3DKnee e+ Tibial Insert
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of 3DKnee e+ Tibial Insert by Encore Medical, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1213-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-01 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Encore Medical |
| Distribution | CA |
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Reason
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.
Identifiers
| code_info | Model/Catalog Number 391-15-708. Lot/Serial Number 59602230. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1213-2013%22
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