Synthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss
Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects 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, and the hazard involves a risk of harm (loss of sterility) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 21 units of the 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number 355.042S. These reaming rods 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 package seal.
The affected lot number is H354470, with a manufacturing date of May 27, 2017, and an expiration date of April 30, 2026. The products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada, between May 31, 2017, and June 20, 2017.
Healthcare providers and facilities should stop using the affected products and contact Synthes (USA) Products LLC for further instructions on return or replacement.
The recalled product
- Product
- 2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 21
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 31-May-217 to 20-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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