| Date Initiated by Firm | June 29, 2004 |
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| Date Posted | July 27, 2004 |
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| Recall Status1 |
Terminated 3 on November 24, 2004 |
| Recall Number | Z-1221-04 |
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| Recall Event ID |
29495 |
| 510(K)Number | K021604 |
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| Product Classification |
Holder, Head, Neurosurgical (Skull Clamp) - Product Code HBL
|
| Product | MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 |
|---|
| Code Information |
Lot Code: #42358 |
Recalling Firm/
Manufacturer |
Integra LifeSciences Corporation
4900 Charlemar Drive
Cincinnati OH 45227
|
| For Additional Information Contact |
800-755-6381 |
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Manufacturer Reason
for Recall | Skull pins, which fractured below device specifications during QC testing, were distributed. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for replacement. |
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| Quantity in Commerce | 69 skull pins were distributed. |
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| Distribution | The product was distributed to the following states:
NY, TX, MD, CO |
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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.
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| 510(K) Database | 510(K)s with Product Code = HBL
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