MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020
This recall has been terminated (originally issued July 27, 2004).
- Company
- Integra Lifesciences Corporation
- Recall Initiated
- June 29, 2004
- Posted
- July 27, 2004
- Terminated
- November 24, 2004
- Recall Number
- Z-1221-04
- Quantity
- 69 skull pins were distributed.
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Skull pins, which fractured below device specifications during QC testing, were distributed.
Distribution
The product was distributed to the following states: NY, TX, MD, CO
Lot / Code Info
Lot Code: #42358
Root Cause
Other
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.
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