Recall Z-0193-2018— Pro-Med Instruments Gmbh

Name: FDA recall Z-0193-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-02

Class II · Terminated

Class II FDA medical device recall by Pro-Med Instruments Gmbh, initiated 2017-11-02, terminated 2018-07-11. It names one FDA 510(k) clearance: K001808. 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: 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..

Recalling firm: Pro-Med Instruments Gmbh
Classification: Class II
Status: Terminated
Initiated: 2017-11-02
Terminated: 2018-07-11
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K001808 — DORO HEADREST SYSTEMPro-Med Instruments GmbH·cleared 2000-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.