Z-1213-2013 Class II Terminated
FDA device recall Z-1213-2013 was initiated by Encore Medical, Lp on Apr 1, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jul 1, 2013). Affected quantity: 5.
Recall details
- Product Type
- Devices
- Report Date
- May 8, 2013
- Initiation Date
- Apr 1, 2013
- Termination Date
- Jul 1, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product description
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.
Distribution pattern
US Distribution to the state of California and International Distribution to the country of Venezuela.
Code information
Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1213-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026