Food, drugs, devices › Encore Medical, Lp
Device recall: 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
FDA enforcement event 64859 is a device recall by Encore Medical, Lp of Austin, TX, initiated 1 Apr 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 1 Jul 2013. Initiation: voluntary: firm initiated. Encore Medical, Lp has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Encore Medical, Lp, Austin, TX.
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
"US Distribution to the state of California and International Distribution to the country of Venezuela."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1213-2013 | 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. | 5 | Class II | Terminated | 8 May 2013 |
Context
Other enforcement events for Encore Medical, Lp
All 61 events for Encore Medical, Lp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the state of California and International Distribution to the country of Venezuela."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.