Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 13, 2017
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 par…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pro-Med Instruments Gmbh recalled pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per b… - a moderate-severity action.
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per b… was recalled by Pro-Med Instruments Gmbh in December 13, 2017. Reason: The firm received reports of two breakages of the pin tips which occurred during two identical surgery proced…. Check the official notice for the remedy. Verify recall #Z-0193-2018 with the FDA Devices before acting.
The recall
Pro-Med Instruments Gmbh issued this moderate-severity FDA Devices recall-The firm received reports of two breakages of the pin tips which occurred during two identical surgery proced….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- December 13, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0193-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0193-2018) was formally reported on December 13, 2017, with the manufacturer initiating the action on November 2, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Pro-Med Instruments Gmbh is listed as the recalling firm, operating out of Freiburg Im Breisgau, N/A. Federal records list the affected scope as 1142 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1142 units
Related Recalls
6
3 from same agency
Product 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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0193-2018 |
| Date reported | December 13, 2017 |
| Date initiated | November 2, 2017 |
| Recalling firm | Pro-Med Instruments Gmbh |
| Firm location | Freiburg Im Breisgau, N/A |
| Affected scope | 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0193-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pro-Med Instruments Gmbh. Units affected: 1142 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0193-2018.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0193-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.