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U.S. Department of Health and Human Services

Class 2 Device Recall DORO(R) Sterile Disposable Skull Pins

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  Class 2 Device Recall DORO(R) Sterile Disposable Skull Pins see related information
Date Initiated by Firm November 02, 2017
Create Date December 05, 2017
Recall Status1 Terminated 3 on July 11, 2018
Recall Number Z-0193-2018
Recall Event ID 78501
510(K)Number K001808  
Product Classification Holder, head, neurosurgical (skull clamp) - Product Code HBL
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.
Code Information Lots: 17041 and 17272
Recalling Firm/
Manufacturer		 Pro-Med Instruments Gmbh
Botzinger Str. 38
Freiburg Im Breisgau Germany
Manufacturer 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 Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HBL and Original Applicant = PRO-MED INSTRUMENTS GMBH
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