Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-Packaging
Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging error (mis-pack) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Encore Medical, Lp is recalling 9 units of the 3DKNEE(TM) SYSTEM e+ Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708. The recall is due to a mis-packaging error where a size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
The affected product is Lot # 339G1045. The distribution pattern includes worldwide distribution to the United States (nationwide) to the states of AL, TX, UT, and CA, as well as to India and Germany.
Healthcare providers and patients should check their inventory and records for this specific lot number and product reference. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions.
The recalled product
- Product
- 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to c
- Manufacturer
- Encore Medical, Lp
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 339G1045
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, Lp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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