Class II — Synthes Produktions GmbH
| Recalling firm | SYNTHES GMBH / Synthes Produktions GmbH |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| 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. |
| Quantity | 41 units |
| Distribution | International distribution including in the country of Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan. |
| Initiated | 2020-06-16 |
| Classified | 2020-07-30 |
| Terminated | 2022-04-15 |
| Recall number | Z-2739-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Synthes Produktions GmbH (Z-2739-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85951/
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