Z-1438-2010

2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003

Name: Z-1438-2010 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
Creator: Trilliant Surgical LTD
Published: 2009-04-14
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2009-04-14 / Terminated / root cause: design

FDA source

Trilliant Surgical LTD began a recall of 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003 on 2009-04-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1438-2010
Status: Terminated
Initiated: 2009-04-14
Posted: 2010-04-26
Terminated: 2010-05-03
Recalling firm: Trilliant Surgical LLC
Product: 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
Product code: HWC Screw, Fixation, Bone
Reason for recall: 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 tag: design
FDA 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 in commerce: 32 units
Distribution: WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
Product codes and lots: Lot #0924081

Product code HWC

K081510Class IITiger Cannulated Screw SystemTrilliant Surgical, Ltd. / cleared 2008-08-04

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)