Recall Z-2739-2020— Synthes Produktions GmbH

Name: FDA recall Z-2739-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-16

Class II · Terminated

Class II FDA medical device recall by Synthes Produktions GmbH, initiated 2020-06-16, terminated 2022-04-15. It names one FDA 510(k) clearance: K050608. Product: MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.. Reason: One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm)..

Recalling firm: Synthes Produktions GmbH
Classification: Class II
Status: Terminated
Initiated: 2020-06-16
Terminated: 2022-04-15
Firm location: Oberdorf Bl, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K050608 — SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEMSynthes (Usa)·cleared 2005-05-18

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

MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.

Reason for recall

One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).

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