| Date Initiated by Firm | June 04, 2015 |
|---|
| Date Posted | July 10, 2015 |
|---|
| Recall Status1 |
Terminated 3 on March 22, 2016 |
| Recall Number | Z-2058-2015 |
|---|
| Recall Event ID |
71423 |
| 510(K)Number | K111663 |
|---|
| Product Classification |
bone fixation screw - Product Code HRS
|
| Product | A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw |
|---|
| Code Information |
Part number:856135060 Lot: 061300 |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact | Audrey Daenzer
574-372-1570 |
|---|
Manufacturer Reason
for Recall | Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. |
|---|
FDA Determined
Cause 2 | Packaging |
|---|
| Action | On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m. |
|---|
| Quantity in Commerce | 50 units |
|---|
| Distribution | Domestic: None.
International:
Netherlands and Japan |
|---|
| 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 = HRS
|
|---|
