Encore Medical Recalls DJO EMPOWR Knee Locking Tibial Punch Guide
Encore Medical is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide because the device did not sufficiently guide the punch, causing implants to be placed 2-3mm more posterior 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 incorrect implant placement (2-3mm posterior deviation), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Encore Medical, Lp is recalling 2 units of the DJO EMPOWR Knee Locking Tibial Punch Guide (Ref 801-05-042, Lot 252567). The device is a non-sterile medical instrument 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 surgical procedures.
The affected units were distributed to one medical device distributor in California. Healthcare providers and distributors should stop using the affected units and contact Encore Medical, Lp for instructions on return or replacement.
The recalled product
- Product
- DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, 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 252567
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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