Z-1086-2019 Class II Terminated
FDA device recall Z-1086-2019 was initiated by Zimmer Biomet, Inc. on March 1, 2019 and is designated Class II. Reason for recall: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa. The recall status is terminated (terminated May 27, 2020). Affected quantity: 809 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2019
- Initiation Date
- March 1, 2019
- Termination Date
- May 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 809 total
Product Description
Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Reason for Recall
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Code Information
Lot Numbers/UDI Number 523430 (01) 00880304001961 (17) 280804 (10) 523430 523450 (01) 00880304001961 (17) 280727 (10) 523450 860840 (01) 00880304001961 (17) 280806 (10) 860840 860850 (01) 00880304001961 (17) 280809 (10) 860850 860860 (01) 00880304001961 (17) 280806 (10) 860860