Synthes Recalls MatrixMIDFACE Screws Due to Incorrect Size Marking
Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Screws because the body clip was etched with the wrong size number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a labeling error (incorrect size marking) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes Produktions GmbH is recalling 41 units of MatrixMIDFACE Emergency Screws, 1.8mm, self-tapp, L 12mm, in Clip. The recall is due to a packaging error where the body clip was etched with the number 3, representing 3mm, instead of the correct number 12, representing 12mm.
The affected lot is # 41P2340. The product was distributed internationally, including in Australia, Germany, New Zealand, Slovakia, Spain, and Taiwan. The intended use for these devices is in the 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.
Healthcare providers should stop using the affected units and contact Synthes Produktions GmbH for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Synthes Produktions GmbH
- Hazard
- Affected units
- 41
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 41P2340
Distribution
Distribution scope not specified by the agency.
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