| Date Initiated by Firm | November 10, 2006 |
|---|
| Date Posted | January 09, 2007 |
|---|
| Recall Status1 |
Terminated 3 on April 16, 2008 |
| Recall Number | Z-0466-2007 |
|---|
| Recall Event ID |
36868 |
| 510(K)Number | K990622 |
|---|
| Product Classification |
Drill Bit - Product Code HTW
|
| Product | BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. |
|---|
| Code Information |
Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP. |
| FEI Number |
3003418325
|
Recalling Firm/
Manufacturer |
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
|
| For Additional Information Contact | Jon Caparotta
609-936-2495 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = HTW
|
|---|
