TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) RE
FDA device recall Z-1636-2014 · posted 2014-05-20 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 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.
- Date initiated
- 2014-04-04
- Date posted
- 2014-05-20
- Date terminated
- 2017-07-01
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIGEN INTERTAN (K040212) | Smith & Nephew, Inc. | 2004-02-20 |