Synvasive Oscillating Saw Blades Recalled for Incorrect Cutting Width Labeling
Synvasive Technology Inc is recalling 14 oscillating saw blades that incorrectly identify the cutting width as 25mm instead of 19mm.
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 the hazard is a labeling error regarding blade dimensions. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
Synvasive Technology Inc is recalling 14 units of Zimmer Oscillating Flat - TS ST Hub saw blades. The affected products are identified by Synvasive Part No. 11-4770, Part No. 19075127YT1, and Lot Nos. 45104 and 43054. These oscillating surgical saw blades are intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures.
The recall was initiated because the two lots of saw blades incorrectly identify the blade cutting width as 25mm, whereas the correct specification is 19mm. This labeling error could lead to the use of an incorrect blade size during surgical procedures.
The 14 affected units were distributed in the United States to one location each in Connecticut, Massachusetts, and California. Healthcare facilities and consumers should stop using these specific saw blades and contact Synvasive Technology Inc for further instructions.
The recalled product
- Product
- Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with…
- Manufacturer
- Synvasive Technology Inc
- Hazard
- Affected units
- 14
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 (3)
- Synvasive Part number: 11-4770
- Part number: 19075127YT1
- Lot numbers: 45104 and 43054.
Distribution
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