The Recall Desk
HighFDA (Devices)·Z-0901-2018·Announced 2018-03-14

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.

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 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
Category
Medical Device — Orthopedic Instrument
Hazard
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

Distributed nationwide across the United States.

The notice also names 52 states specifically:

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.

See all 7 products in this recall →

Related recalls

Same manufacturer · Synthes (USA) Products LLC

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Same hazard · sterility compromise

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