Recall Z-0193-2018 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Pro-Med Instruments Gmbh
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.
| Date | Nov 2, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 product |
| Quantity | 1142 units |
| Distribution | Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001808 | DORO HEADREST SYSTEM Pro-Med Instruments GmbH, Aug 4, 2000 |