CLASS II Device recall · Reported 8 May 2013 · FDA Enforcement Report
3DKnee e+ Tibial Insert recalled by Encore Medical
Encore Medical is recalling 3DKnee e+ Tibial Insert, distributed nationwide in the US. The recall was initiated on 1 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1213-2013
- FDA event ID
- 64859
- Recalling firm
- Encore Medical, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Apr 2013
- FDA classified
- 2 May 2013
- Reported
- 8 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 1 Apr 2013 | Recall initiated by company | |
| 2 May 2013 | Classified by FDA | +31 days |
| 8 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Where it was distributed
US Distribution to the state of California and International Distribution to the country of Venezuela.
Questions about this recall
Is 3DKnee e+ Tibial Insert recalled?
Yes. Encore Medical recalled 3DKnee e+ Tibial Insert on 1 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1213-2013.
Why was it recalled?
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.
Which lots are affected?
Model/Catalog Number 391-15-708. Lot/Serial Number 59602230.
Where was it sold?
US Distribution to the state of California and International Distribution to the country of Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Encore Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
| Device | CLASS II | Empowr 3d Knee Ins, Ve recalled by Encore Medical | Encore Medical | Packaging Defects | 14 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |