Synthes 3.0 MM TI Cannulated Screw Set Recalled for Cytotoxicity Risk
Synthes, Inc. is recalling 3.0 MM TI Cannulated Screw Instrument and Implant Sets that were exposed to flood water and reprocessed. Testing indicated the components may be cytotoxic.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential cytotoxicity of medical device components, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes, Inc. is recalling the Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set. The recall involves four units of Part Number 145.17E, Lot Number EV01609. These sets were distributed in the states of Wisconsin and Michigan.
The recall was initiated because a screw set was returned from the field for destruction after being exposed to flood water. The set was erroneously reprocessed and returned to the field. Initial investigative testing indicated that the components within the set may be cytotoxic.
Healthcare providers and facilities in Wisconsin and Michigan should check their inventory for the specific part and lot numbers listed in the recall notice. If the affected product is found, it should be removed from use and returned to Synthes, Inc. according to the company's instructions.
The recalled product
- Product
- Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
- Manufacturer
- Synthes, Inc.
- Affected units
- 4
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 (2)
- Part Number: 145.17E Lot Number: EV01609
- and 292.623.
Distribution
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