Synthes 8.5 MM Medullary Reamer Recalled Due to Intraoperative Breakage
Synthes USA HQ, Inc. is recalling 2,979 units of the 8.5 MM Medullary Reamer because the reamer head can break during surgery, leaving unretrieved fragments of non-implant grade material.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the potential for unretrieved fragments of non-implant grade material to remain in a patient during surgery, which poses a significant risk of injury.
Plain-English summary
Synthes USA HQ, Inc. is recalling 2,979 units of the Synthes 8.5 MM Medullary Reamer. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-0202-2014. The affected products are identified by Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257.
The recall was initiated after complaints were received regarding intraoperative reamer head breakages. This defect can allow for unretrieved fragments of non-implant grade material to remain in the patient during surgery. The product is an orthopedic manual surgical instrument intended for use in orthopedic surgery.
The affected units were distributed nationwide in the United States, as well as in Canada and Mexico. Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the…
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 2,979
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 No. 352.085 with lot numbers 20141 through 24510
- and 4399543 through 5870257
Distribution
Distributed nationwide across the United States.
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