| Date Initiated by Firm | May 09, 2007 |
|---|
| Date Posted | November 01, 2007 |
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| Recall Status1 |
Terminated 3 on March 07, 2008 |
| Recall Number | Z-0080-2008 |
|---|
| Recall Event ID |
38775 |
| 510(K)Number | K062113 |
|---|
| Product Classification |
Shoulder prosthesis - Product Code KWS
|
| Product | ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis.
Distal Diameter - 7 to 15mm;
Hydroxylapatite coated;
Titanium Plasma Spray;
Howmedica Osteonics Corp. |
|---|
| Code Information |
Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612. All lot codes. |
Recalling Firm/
Manufacturer |
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
|
| For Additional Information Contact | Larry Ross
201-831-5972 |
|---|
Manufacturer Reason
for Recall | The plasma spray may delaminate from the proximal portion of the humeral stem. |
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FDA Determined
Cause 2 | Process control |
|---|
| Action | Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards. |
|---|
| Quantity in Commerce | 232 units |
|---|
| Distribution | One hospital in Akron OH and 12 Stryker branches/agencies |
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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 = KWS
|
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