Synvasive Reciprocating Saw Blades Recalled for Labeling Errors
Synvasive Technology is recalling 3,442 reciprocating saw blades due to incorrect labeling regarding blade type, expiration dates, and compatible power systems.
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 source text describes only labeling errors without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Synvasive Technology, Inc. is recalling 3,442 units of reciprocating saw blades distributed by Zimmer and Synvasive Technology. These sterile surgical saw blades are used to resect damaged cartilage and/or bone in orthopaedic reconstructive procedures, such as total knee replacements.
The recall is due to labeling errors on the product packaging. Specifically, some pouches are labeled as containing oscillating saw blades when they actually contain reciprocating saw blades. Additionally, the box bar code date does not match the human-readable expiration date on some units, and labels incorrectly state compatibility with the Zimmer/Synthes handset instead of the Zimmer Universal Power System.
The affected products were distributed worldwide, including in the United States and various countries in Europe, Asia, and the Middle East. Specific lot numbers are listed in the official recall documentation. Users should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an…
- Manufacturer
- Synvasive Technology Inc
- Hazard
- Affected units
- 3,442
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)
- Lots Numbers included in Recall: 1X311
- 01251
- 16325
- 15023
- 15024
- 1Y224
- 23326
- 0X401
- 26385
- 1Y174
- 17151
- 0Y280
- 17150
- 22028
- 28114
- 19071
- 23372
- 23346
- 23504
- 23505
Distribution
Distributed nationwide across the United States.
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