Z-1139-2017 Class II Terminated
FDA device recall Z-1139-2017 was initiated by Encore Medical, Lp on January 10, 2017 and is designated Class II. Reason for recall: The Empowr PS Insert was reported as missing the impaction slot feature. The recall status is terminated (terminated May 11, 2017). Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 10, 2017
- Termination Date
- May 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Reason for Recall
The Empowr PS Insert was reported as missing the impaction slot feature.
Distribution Pattern
Nationwide Distribution to CO, NY, and FL
Code Information
035U1000