TRIGEN(R) INTERTAN(TM) 10MM X 18 CM NAIL, 125o, REF 71675201, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 3811
FDA device recall Z-2258-2014 · posted 2014-08-17 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
- Action taken
- Smith & Nephew Issued an Urgent Product Recall dated July 2, 2014 to all affected customers via E-mail and/or FedEx . The notification identified the effective product, problem and actions to be taken. Customers were instructed to: Inspect inventory and locate any unused affected devices, cease distribution and use of those products, quarantine them immediately, complete the last two columns in the Inventory Return Certification Form, and return any affected product to the address provided. For questions call 901-396-2121
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 601 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHINA, INDIA, UAE, JAPAN, SOUTH AFRICA, SOUTH KOREA, UNITED KINGDOM. AUSTRIA, NORWAY, POLAND, PORTUGAL
- Date initiated
- 2014-07-02
- Date posted
- 2014-08-17
- Date terminated
- 2019-08-20
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIGEN INTERTAN (K040212) | Smith & Nephew, Inc. | 2004-02-20 |