TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN
FDA device recall Z-1132-2013 · posted 2013-04-17 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
- Action taken
- Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 23 units
- Distribution
- Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
- Date initiated
- 2013-03-06
- Date posted
- 2013-04-17
- Date terminated
- 2019-08-16
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIGEN LOW PROFILE BONE SCREW (K111025) | Smith & Nephew, Inc. | 2011-07-01 |