DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Reported: January 17, 2018 Initiated: December 12, 2017 #Z-0326-2018
Product Description
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason for Recall
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 2 units
- Distribution
- One medical device distributor in California.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.. Recalled by Encore Medical, Lp. Units affected: 2 units.
Why was this product recalled? ▼
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2018. Severity: Moderate. Recall number: Z-0326-2018.
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