—#49477

Product

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

FDA product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K990622
Affected lot / code info: Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide to distributors, hospitals and Integra Sales Reps.

Timeline

Recall initiated: 2006-11-10
Posted by FDA: 2007-01-09
Terminated: 2008-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49477. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.