Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss
Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.
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 where a loss of sterility poses a risk of harm (infection), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods, Ball tip with extension, 950 mm, sterile, Part Number 351.707S. The recall is due to a possible lack of product sterility caused by potential gaps or channeling in the package seal. These devices are intended for guiding reamers during orthopedic surgery.
The affected products were distributed from April 17, 2017, to June 8, 2017. Distribution was nationwide in the United States, including Puerto Rico, and in Canada. The specific lot numbers involved are H040501, H105498, and H213824.
Healthcare facilities and consumers should stop using these specific reaming rods and contact Synthes (USA) Products LLC for further instructions or a replacement.
The recalled product
- Product
- 2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 216
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)
- Distributed 17-Apr-2017 to 8-June-2017
Distribution
Part of a larger recall action
This product is one of 7 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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