Recall Z-1133-2022
Smith & Nephew Orthopaedics GmbH · initiated April 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Codes / lots: Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989
Reason for recall
Right nails were anodized, marked, and labelled as left nails and vice versa
FDA-determined cause: Under Investigation by firm
Action taken
The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.
Details
- Recall number
- Z-1133-2022
- Initiated
- April 22, 2022
- Product code
- JDS – Nail, Fixation, Bone
- Quantity
- 17 units
- Distribution
- Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
- Recalling firm
- Smith & Nephew Orthopaedics GmbH, Tuttlingen