Z-0466-2007

BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment

Name: Z-0466-2007 BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment
Creator: Integra LifeSciences Corp.
Published: 2006-11-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2006-11-10 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment on 2006-11-10. The reason FDA records is "Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0466-2007
Status: Terminated
Initiated: 2006-11-10
Posted: 2007-01-09
Terminated: 2008-04-16
Recalling firm: Integra LifeSciences Corporation
Product: BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
Product code: HTW Bit, Drill
Reason for recall: Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
Root cause tag: manufacturing process
FDA root cause: Other
Action: An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
Quantity in commerce: 107 in US.
Distribution: Nationwide to distributors, hospitals and Integra Sales Reps.
Product codes and lots: Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.

Product code HTW

K990622Class IIBold ScrewNew Deal, S.A. / cleared 1999-04-29

MDM coverage of this record lists here, newest first.

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)