FDA Medical Device Recalls (openFDA)
Synthes Produktions GmbH: 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.
- Recall number
- Z-2739-2020
- Recalling firm
- Synthes Produktions GmbH
- 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.
- Status
- Terminated
- Initiated
- 2020-06-16
- Posted
- not on file
- Terminated
- 2022-04-15
- 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).
- Root cause
- Under Investigation by firm
- Action
- DePuy Synthes issued urgent field safety notice in June 26, 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.
- Quantity
- 41 units
- Distribution
- International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan.
- Lot, serial or model codes
- Lot # 41P2340
- 510(k) numbers
- ["K050608"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 3002807305
- Firm city
- Oberdorf
- Firm state
- BL
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28