Synthes Reaming Rods Recalled for Potential Sterility Seal Defects
Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Synthes (USA) Products LLC is recalling 6,257 units of 2.5 mm Reaming Rods, Ball tip, 950 mm, sterile, Part Number 351.706S. These medical devices are intended for guiding reamers during orthopedic surgery. The recall was initiated due to a possible lack of product sterility caused by potential gaps or channeling in the package seal.
The affected units were distributed nationwide in the United States, including Puerto Rico, and in Canada between March 21, 2017, and June 23, 2017. The source text lists specific lot numbers and manufacturing dates for the affected inventory. No illnesses or injuries have been reported in the source text.
Healthcare facilities and distributors should stop using the affected reaming rods and contact Synthes (USA) Products LLC for further instructions. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 6,257
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 21-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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