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.
Recall
- Recall Number
- Z-0193-2018
- Event Number
- 78501
- Firm
- Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany
- FEI Number
- 3003923584
- Product Code
- HBL
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- November 2, 2017
- Terminated
- July 11, 2018
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.
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.
Pro-Med Instruments Gmbh initiated their recall by email on October 30, 2017. The recall notice stated the following: " Actions to be taken by the customer I user: Review this notification and ensure that all users of the affected products are informed of this urgent field safety notice. If you have transferred the affected products to third parties, please forward a copy of this letter or inform the below mentioned contact person. Customers were instructed to check their stock for any affected products If you have any affected products on stock, please quarantine them and send the products back to us. You will receive a replacement as soon as we have received your "Acknowledgement and Receipt Form" and know your current stock. Check any products or records of the affected LOTs used prior to receipt of this field safety notice if the tips have been intact after the surgery. If the tips have not been intact, ensure that any remaining parts are removed from the patient. There are no further specific patient monitoring actions necessary related to this Field Safety Notice. If after reviewing this notification you have any further questions or queries please discuss them with your pro med instruments sales representative Please complete the attachment "Acknowledgement and Receipt Form" and return by Fax or email (see under nr. 8. below) to pro med instruments GmbH to confirm receipt by the 10th of November 2017 at the latest."
Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
1142 units