Z-1133-2022 Class II Ongoing
FDA device recall Z-1133-2022 was initiated by Smith & Nephew Orthopaedics GmbH on April 22, 2022 and is designated Class II. Reason for recall: Right nails were anodized, marked, and labelled as left nails and vice versa The recall status is ongoing. Affected quantity: 17 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- April 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product Description
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Reason for Recall
Right nails were anodized, marked, and labelled as left nails and vice versa
Distribution Pattern
Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
Code Information
Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989