Z-0193-2018 Class II Terminated
FDA device recall Z-0193-2018 was initiated by Pro-Med Instruments Gmbh on November 2, 2017 and is designated Class II. Reason for recall: The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin ti… The recall status is terminated (terminated July 11, 2018). Affected quantity: 1142 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- November 2, 2017
- Termination Date
- July 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1142 units
Product Description
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
Reason for Recall
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.
Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
Code Information
Lots: 17041 and 17272