Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a surgical instrument, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling 1,144 units of 2.5 mm Reaming Rods, Ball tip, 1150 mm, sterile, Part Number 351.708S. These medical devices are intended for guiding reamers during orthopedic surgery. The recall is due to a possible lack of product sterility caused by potential gaps or channeling in the seal of the package.
The affected products were distributed nationwide in the United States, including Puerto Rico, and in Canada between March 10, 2017, and June 23, 2017. The recall includes specific lot numbers manufactured in March, April, and May 2017, with expiration dates ranging from January 2026 to March 2026.
Healthcare facilities and consumers should stop using the affected reaming rods and contact Synthes (USA) Products LLC for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 1,144
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 10-Mar-2017 to 23-Jun-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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