FDA Device recall Z-0193-2018
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY T…
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY T… by Pro Med Instruments, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0193-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-02 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Pro Med Instruments |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lots: 17041 and 17272 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Pro Med Instruments
- DORO¿ Easy-Connect Navigation Adaptor
FDA Device · Class II · 2025-06-04 · Pro Med Instruments - DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments - DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments - DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal su…
FDA Device · Class I · 2018-09-26 · Pro Med Instruments
All Pro Med Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0193-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.