Encore Medical Recalls EMPOWR Porous Knee System Tibial Punch
Encore Medical is recalling two units of the EMPOWR Porous Knee System Tibial Punch because the locking guide failed to properly guide the punch, causing implants to be placed 2-3mm more posterior than intended.
What this means for you
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 the implant being placed 2-3mm more posterior than intended. This represents a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Encore Medical, Lp is recalling two units of the EMPOWR Porous Knee System Tibial Punch, Large, Ref 801-05-204, Non Sterile. The recall is limited to Lot 252564. The product is a medical device used in orthopedic surgery.
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 the surgical procedure.
The affected units were distributed to one medical device distributor in California. Healthcare providers and patients who may have used these specific units should contact Encore Medical, Lp for further instructions on how to proceed.
The recalled product
- Product
- EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, 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.
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