Recall Z-1279-2012
Codman & Shurtleff, Inc. · initiated February 9, 2012
Product
Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit.
Codes / lots: Lot Numbers: CMJB1B CMJB1C CMJB1D CMJB67 CMJB68 CMJB69 CMJB7B CMJCR6 CMJCR7 CMJCR8 CMJC1F CMJC1G CMJC1H CMJC1J CMJC1K CMJC1L CMJC1M CMKBKF CMKBKG CMKBKH CMKBK3 CMKBK4 CMKBK5 CMKBK6 CMKBK7 CMKBZ3 CMKBZ4 CMKBZ5 CMKBZ6 CMKBZ7 CMKB2Y CMKB2Z CMKB20 CMKB8L CMKCKG CMKCKH CMLBH6 CMLBMY CMLBMZ CMLBM0 CMLBM1 CMLB5P CMLB5R CMLCJR CMLCJT CMLCJV CMLC5G CMLC5H CMLC5J CMMBFR CMMBFT CMMBL5 CMMBL6 CMMCF3 CMMCF4 CMMCF5 CMMCF6 CMMC4H CMMC4J CMMC4K CMMC4L CMMC4M CMNBD9 CMNBZ4 CMNBZ5 CMNBZ6 CMNBZ7 CMNBZ8 CMNCHY CMNCHZ CMNCLW CMNCLY CMNCLZ CMNCL0 CMNCL1 CMNCL2 CMNCW5 CMNCW6 CMNCW7 CMLBJH CMMBD9 CMMCFC CMNCC1 CMNCC2
Reason for recall
Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill
FDA-determined cause: Nonconforming Material/Component
Action taken
Codman issued "Urgent - Voluntary Product Recall Notification" letters on 2/9/12 via Fedx in the US and requested accounts examine inventory and return product. An Acknowledgement Form was requested to be returned. Outside the US affiliates were notified to recall to their accounts. Questions were directed to Customer Service (800) 225-0460.
Details
- Recall number
- Z-1279-2012
- Initiated
- February 9, 2012
- Posted by FDA
- March 22, 2012
- Terminated
- September 11, 2015
- Product code
- GWM – Device, Monitoring, Intracranial Pressure
- Quantity
- 4056 kits
- Distribution
- Worldwide Distribution - USA, and the countries of Canada, Austria, Brazil, Belgium, Columbia, China, Denmark, Estonia, Spain, Finland, France, Great Britain, Germany, India, Italy, Japan, Lithuania, Netherlands, New Zealand, Oman, Mexico, Portugal, Russia, Singapore, SIovenia, and Switzerland.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA