FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
- Recall number
- Z-0466-2007
- Recalling firm
- Integra LifeSciences Corp.
- Product
- BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
- Status
- Terminated
- Initiated
- 2006-11-10
- Posted
- 2007-01-09
- Terminated
- 2008-04-16
- Reason
- 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
- Other
- Action
- An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
- Quantity
- 107 in US.
- Distribution
- Nationwide to distributors, hospitals and Integra Sales Reps.
- Lot, serial or model codes
- Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.
- 510(k) numbers
- ["K990622"]
- PMA numbers
- not on file
- Product code
- HTW
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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