FDA Medical Device Recalls (openFDA)
Trilliant Surgical Ltd.: Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
- Recall number
- Z-2339-2018
- Recalling firm
- Trilliant Surgical Ltd.
- Product
- Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
- Status
- Terminated
- Initiated
- 2018-03-27
- Posted
- not on file
- Terminated
- 2020-06-04
- Reason
- Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.
- Root cause
- Other
- Action
- On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns.
- Quantity
- 90
- Distribution
- U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
- Lot, serial or model codes
- Lot: 603600
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MDM
- 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