pmi — Class II medical device recall Z-0193-2018
Terminated recall by Pro-Med Instruments Gmbh, reported 2017-12-13, distributed nationwide. The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedu
| Recall number | Z-0193-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pro-Med Instruments Gmbh, Freiburg Im Breisgau, N/A, Germany |
| Recall initiated | 2017-11-02 |
| Classified | 2017-12-05 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2018-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, DE, ES, FR, GB, HU, IE, IN, IT, JP, SA, ZA |
| Quantity | 1,142 units |
| Reason classes | device malfunction |
| Lot numbers | 17041, 17272 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0193-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.