Z-0915-2022 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
- 433 5-packs
Product Description
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
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 Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255