FDA Medical Device Recalls (openFDA)
Trilliant Surgical LTD: 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
- Recall number
- Z-1438-2010
- Recalling firm
- Trilliant Surgical LTD
- Product
- 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
- Status
- Terminated
- Initiated
- 2009-04-14
- Posted
- 2010-04-26
- Terminated
- 2010-05-03
- Reason
- Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
- Root cause
- Other
- Action
- Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.
- Quantity
- 32 units
- Distribution
- WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
- Lot, serial or model codes
- Lot #0924081
- 510(k) numbers
- ["K081510"]
- 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