Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage
Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.
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 risk of harm (un-retrieved fragments) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Synthes (USA) Products LLC is recalling 4,329 units of 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems. These are orthopedic manual surgical instruments intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. The affected units were distributed worldwide.
The recall is being conducted because there is a possibility for intraoperative reamer head breakages. Such breakages could allow for un-retrieved fragments of non-implant grade material to remain in the patient. The source text notes that additional lot numbers have been identified for this recall.
No new adverse events have been reported in connection with this recall. Healthcare providers and patients should contact Synthes (USA) Products LLC for further instructions regarding the affected devices.
The recalled product
- Product
- 8.5mm Reamer Head for Flexible Intramedullary Nailing System; 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) Products LLC
- Affected units
- 4,329
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 (1)
- Part Number 352.085
Distribution
Distribution scope not specified by the agency.
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