Synthes Flexible Medullary Reamer Recalled Due to Cleaning and Corrosion Risks
Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.
What this means for you
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 involves a medical device with a potential for harm due to corrosion and foreign material introduction, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes USA HQ, Inc. is recalling 13,050 units of the Synthes Flexible Medullary Reamer. The product is intended to facilitate the preparation of the intramedullary cavity. The recall covers all lots with part numbers 359.106 through 359.115, which were distributed nationwide.
The recall was initiated because the product's coiled design makes it difficult to clean. This design feature creates a potential for corrosion on the device. If corrosion or retained undefined material that could not be adequately cleaned is introduced at the operative site, there is a potential for harm to the patient.
Healthcare providers and facilities that have received these devices should stop using them and contact Synthes USA HQ, Inc. for further instructions on the recall process.
The recalled product
- Product
- Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 13,050
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 (10)
- All lots with part number 359.106
- 359.107
- 359.108
- 359.109
- 359.110
- 359.111
- 359.112
- 359.113
- 359.114
- 359.115
Distribution
Distributed nationwide across the United States.
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