Z-0193-2018Class II

pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters...

Name: Z-0193-2018 pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters...
Creator: Pro-Med Instruments Gmbh
Published: 2017-11-02
License: https://open.fda.gov/license/

Black Forest Medical GmbH / initiated 2017-11-02 / Terminated

FDA source

Pro-Med Instruments Gmbh began a 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 The DORO(R) Skull... on 2017-11-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0193-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Posted: 2017-12-05
Terminated: 2018-07-11
Recalling firm: Black Forest Medical GmbH
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.
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
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.
FDA 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 products back to us. You will receive a replacement as soon as we have received your "Acknowledgement and Receipt Form" and know your current stock. Check any products or records of the affected LOTs used prior to receipt of this field safety notice if the tips have been intact after the surgery. If the tips have not been intact, ensure that any remaining parts are removed from the patient. There are no further specific patient monitoring actions necessary related to this Field Safety Notice. If after reviewing this notification you have any further questions or queries please discuss them with your pro med instruments sales representative Please complete the attachment "Acknowledgement and Receipt Form" and return by Fax or email (see under nr. 8. below) to pro med instruments GmbH to confirm receipt by the 10th of November 2017 at the latest."
Quantity in commerce: 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
Product codes and lots: Lots: 17041 and 17272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0193-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-05

Product code HBL

K001808Class IIDoro Headrest SystemPro-Med Instruments GmbH / cleared 2000-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)