Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
This recall has been terminated (originally issued January 6, 2017).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- December 8, 2016
- Posted
- January 6, 2017
- Terminated
- May 17, 2017
- Recall Number
- Z-0960-2017
- Quantity
- 50 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution
Lot / Code Info
Lot: TSL003191, TSL003637, TSL004101, TSL004395
Root Cause
Under Investigation by firm
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.