Synthes Ti Button Plate Recalled for Inaccurate MR Safety Labeling
Synthes (USA) Products LLC is recalling 6,255 Ti Button Plate units because their MR safety information does not meet current ASTM standards.
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 and involves a labeling error regarding MR safety standards. No injuries or illnesses are reported, and the hazard is related to compliance with safety labeling rather than a direct structural defect or contamination.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 6,255 units of the Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue. The recall was initiated because the affected devices were distributed and/or labeled with MR Safety information that does not meet the current ASTM standard.
The recalled devices were distributed to hospitals and medical facilities across the United States, including all 50 states, the District of Columbia, and Puerto Rico. The specific lot numbers and part numbers affected are listed in the official recall documentation.
Healthcare providers and patients should verify the lot numbers of their devices against the recall list. If a device is affected, providers should contact Synthes (USA) Products LLC for further instructions on replacement or corrective action.
The recalled product
- Product
- Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 6,255
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 (20)
- Lot Numbers: 1749148
- 1896349
- 3057585
- 3126474
- 3277587
- 3527962
- 3666979
- 3723149
- 3754359
- 3754360
- 3800237
- 3800239
- 3825498
- 4182364
- 4182365
- 4184238
- 4184239
- 4184240
- 4184241
- 4186156
Distribution
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