Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-packaging Error
Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a mis-packaging error (wrong size/side) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Encore Medical, Lp is recalling 9 units of 3DKnee System e+ Tibial Inserts, specifically the LEFT Sz 6 / 11mm (REF 391-11-706), under FDA recall number Z-2658-2017. The recall is due to a mis-packaging error where a size 6 left box and pouch contained a size 8 right 3DKnee Tibial Insert.
The affected product is manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with alpha-tocopherol. The distribution pattern includes the United States (AL, TX, UT, CA) and international locations in India and Germany. The specific lot number is 292G1910.
Healthcare providers and patients should stop using the affected inserts and contact Encore Medical for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, 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…
- 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 # 292G1910
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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