MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
FDA device recall Z-1221-04 · posted 2004-07-27 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corporation
- Reason for recall
- Skull pins, which fractured below device specifications during QC testing, were distributed.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBL
- Quantity affected
- 69 skull pins were distributed.
- Distribution
- The product was distributed to the following states: NY, TX, MD, CO
- Date initiated
- 2004-06-29
- Date posted
- 2004-07-27
- Date terminated
- 2004-11-24
- Location
- Cincinnati, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K021604) | Ohio Medical Instrument Co., Inc. | 2002-07-29 |