Recalls / —
—#126852
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.
- FDA product code
- JDS — Nail, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K040212
- Affected lot / code info
- (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
Why it was recalled
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew Inc
- Address
- 1450 E. Brooks Rd, Memphis, Tennessee 38116
Distribution
- Distribution pattern
- Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Timeline
- Recall initiated
- 2014-04-04
- Posted by FDA
- 2014-05-20
- Terminated
- 2017-07-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #126852. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.