| Date Initiated by Firm | April 12, 2007 |
|---|
| Date Posted | July 23, 2007 |
|---|
| Recall Status1 |
Terminated 3 on July 25, 2007 |
| Recall Number | Z-1065-2007 |
|---|
| Recall Event ID |
37881 |
| 510(K)Number | K000817 |
|---|
| Product Classification |
Hip replacement prosthesis component - Product Code JDI
|
| Product | ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 78758. |
|---|
| Code Information |
Lot #Y131E and 2475. |
Recalling Firm/
Manufacturer |
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
|
Manufacturer Reason
for Recall | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Urgent Device Recall Notification letters distributed to consignees on 04/14/07. Consignees requested to return product to Encore Medical, L.P. |
|---|
| Quantity in Commerce | 2 units. |
|---|
| Distribution | Product distributed to surgical centers in CT, KS and MO. |
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| 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 = JDI
|
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