# FDA recall Z-0193-2018

> **Pro-Med Instruments Gmbh** · Class II · device recall initiated 2017-11-02.

## 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.

## 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

## Key facts

- **Recall number:** Z-0193-2018
- **Recalling firm:** Pro-Med Instruments Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-02
- **Report date:** 2017-12-13
- **Termination date:** 2018-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Freiburg Im Breisgau, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0193-2018

## Citation

> AI Analytics. FDA recall Z-0193-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0193-2018. Source: US FDA. Licensed CC0.

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