FDA Medical Device Recalls (openFDA)
Trilliant Surgical Ltd.: 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.
- Recall number
- Z-0960-2017
- Recalling firm
- Trilliant Surgical Ltd.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2016-12-08
- Posted
- 2017-01-06
- Terminated
- 2017-05-17
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 50 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot: TSL003191, TSL003637, TSL004101, TSL004395
- 510(k) numbers
- K153338
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3007420745
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28