Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk
Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.
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 risk-of-harm product (medical device breakage) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) Drive Shafts, Tube Assemblies, and Reamer Heads. The affected products are sterile and range in size from 12.0mm to 19.0mm. These medical devices are intended to clear the medullary canal of bone marrow and debris and to size the canal for the acceptance of an intramedullary implant or prosthesis.
The recall was initiated because the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. To address this issue, precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.
The affected units were distributed nationwide and internationally to Canada and Switzerland. A total of 132,564 units are included in this recall. Healthcare providers and facilities should check their inventory for the specific part numbers and lot numbers listed in the official recall notice and follow the manufacturer's instructions for the updated surgical technique guide.
The recalled product
- Product
- Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary imp
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 132,564
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 (3)
- Part numbers: 314.742 and 314.743
- 314.745S and 314.746S
- 352.250S-352.265S
Distribution
Distributed nationwide across the United States.
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