Recall Z-1637-2014
Smith & Nephew Inc · initiated April 4, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
Codes / lots: (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188
Reason for recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
FDA-determined cause: Process control
Action taken
The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
Details
- Recall number
- Z-1637-2014
- Initiated
- April 4, 2014
- Posted by FDA
- May 20, 2014
- Terminated
- July 1, 2017
- Product code
- JDS – Nail, Fixation, Bone
- Quantity
- 1,253 units total
- Distribution
- Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
- Recalling firm
- Smith & Nephew Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1636-2014 Class II | TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202…A manufacturing error resulted in the set screw being inserted too deep in the affected nails. | 04/04/2014Terminated |