Integra LifeSciences Corp. BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Model/Catalog number: 159004ND Lot Number: D2CJ/, D2CJ/1, D2PS, E0X4, E14K, E14L, E14M, E14N, E1KM, E1KN, E1X2, E24S, E2JS, E2LP.
Products Sold
Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.
Integra LifeSciences Corp. is recalling BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. due to Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bon. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026