FDA Medical Device Recalls (openFDA)
Trilliant Surgical Ltd.: Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
- Recall number
- Z-0609-2017
- Recalling firm
- Trilliant Surgical Ltd.
- Product
- Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
- Status
- Terminated
- Initiated
- 2016-09-02
- Posted
- 2016-11-17
- Terminated
- 2017-05-19
- Reason
- Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.
- Quantity
- 11
- Distribution
- CA, AZ, WI, FL, NJ, OH
- Lot, serial or model codes
- Lot TSL003721
- 510(k) numbers
- ["K112737"]
- 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