The Recall Desk
HighFDA (Devices)·Z-0904-2018·Announced 2018-03-14

Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential sterility failure.

Plain-English summary

Synthes (USA) Products LLC is recalling 960 units of the 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number 351.76S. 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 seal of the package. The affected units were distributed nationwide in the United States, including Puerto Rico, and in Canada between April 25, 2017, and June 22, 2017.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using any affected units. Consumers should not use these products and should contact the manufacturer for further instructions.

The recalled product

Product
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
960

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 25-Apr-2017 to 22-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 →

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Same manufacturer · Synthes (USA) Products LLC

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Same hazard · sterility failure

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