Z-0916-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 488 5-packs
Product Description
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Reason for Recall
Pouch seals may be open, compromising sterility.
Distribution Pattern
Distribution in the US and territories, Japan, and Canada
Code Information
ROTAWIRE Drive Extra Support, 5 pack, UPN: H74939463005 Individual units within 5-pack are labeled as Single, UPN: H74939463001 Batch numbers: 27630467, 27632712, 27701910, 27705926, 27749752, 27749754, 27792970 27804244, 27805109, 27806091, 27826574, 27826576, 27853736, 27853738, and 27862767 GTIN: 08714729996231