| Date Initiated by Firm |
April 04, 2005 |
| Date Posted |
October 07, 2005 |
| Recall Status1 |
Terminated 3 on August 15, 2007 |
| Recall Number |
Z-0011-06 |
| Recall Event ID |
31984 |
| Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
|
| Product |
Allocraft TLIF Bone Inserter. |
| Code Information |
Catalog No. 483600100; Lot Code: 04C570 |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
|
| For Additional Information Contact |
Dominick Cristofolo
201-831-5247
|
Manufacturer Reason
for Recall |
Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm sent notification letters to their branches/agencies on 4/4/2005. 100% effectiveness to be achieved by completing Product Accountability forms, follow up telephone calls, and follow-up letters as required. |
| Quantity in Commerce |
9 |
| Distribution |
The product was distributed to the firm''s branches/Agencies that distribute the product to hospitals, etc. There are 8 locations. |
| 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.
|
