Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch
Encore Medical is recalling two units of the EMPOWR Tibial Punch because the guide did not sufficiently direct the punch, causing implants to be placed further back than intended.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that resulted in implants being placed in an unintended position, which is a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Encore Medical, Lp is recalling two units of the EMPOWR Porous Knee System Tibial Punch, Medium (REF 801-05-203). The product is a non-sterile medical device used in orthopedic surgery. The specific lot number is 252564.
The recall was initiated because the Locking Punch Guide was not sufficiently guiding the large press fit punch. This defect caused the implant to be placed 2-3mm more posterior than intended during surgery.
The affected units were distributed to one medical device distributor in California. The source text does not specify if the units were used in patients or if any injuries occurred.
The recalled product
- Product
- EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
- Manufacturer
- Encore Medical, Lp
- Affected units
- 2
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 252564
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
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