Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indic
FDA device recall Z-0960-2017 · posted 2017-01-06 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- Reason for recall
- Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
- Action taken
- Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 50 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-12-08
- Date posted
- 2017-01-06
- Date terminated
- 2017-05-17
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tiger Cannulated Screw System (K153338) | Trilliant Surgical, Ltd. | 2016-01-14 |