Recall Z-1221-04 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Integra LifeSciences Corporation
MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
| Date | Jul 27, 2004 (initiated Jun 29, 2004) |
| Status | Terminated |
| Reason | Skull pins, which fractured below device specifications during QC testing, were distributed. |
| Root cause | Other |
| 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. |
| Quantity | 69 skull pins were distributed. |
| Distribution | The product was distributed to the following states: NY, TX, MD, CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021604 | MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Ohio Medical Instrument Co., Inc., Jul 29, 2002 |