Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns
Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product 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 with a risk of harm due to potential loss of sterility, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 63 units of the 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number 359.083S. 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 seal of the package.
The affected units were distributed from May 12, 2017, to June 23, 2017, under Lot Number H270855. The manufacturing date for this lot is May 12, 2017, and the expiration date is April 30, 2026. The products were distributed nationwide in the United States, including Puerto Rico, as well as in Canada.
Healthcare providers and facilities that have received these products should stop using them and contact Synthes (USA) Products LLC for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- 2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 63
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 12-May-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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