Agency classClass IIOur severity:High FDA (Devices)·Z-1952-2013·Announced 2013-08-21

Synthes Flexible Medullary Reamer Recalled Due to Cleaning and Corrosion Risks

Synthes USA is recalling 13,050 Flexible Medullary Reamers because the coiled design makes them difficult to clean, creating a risk of corrosion and foreign material introduction.

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 medical device with a potential for harm due to corrosion and foreign material introduction, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Synthes USA HQ, Inc. is recalling 13,050 units of the Synthes Flexible Medullary Reamer. The product is intended to facilitate the preparation of the intramedullary cavity. The recall covers all lots with part numbers 359.106 through 359.115, which were distributed nationwide.

The recall was initiated because the product's coiled design makes it difficult to clean. This design feature creates a potential for corrosion on the device. If corrosion or retained undefined material that could not be adequately cleaned is introduced at the operative site, there is a potential for harm to the patient.

Healthcare providers and facilities that have received these devices should stop using them and contact Synthes USA HQ, Inc. for further instructions on the recall process.

The recalled product

Product: Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Manufacturer: Synthes USA HQ, Inc.
Category: Medical Device — Surgical Instrument
Hazard: corrosion
foreign-material
Affected units: 13,050

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 (10)

All lots with part number 359.106
359.107
359.108
359.109
359.110
359.111
359.112
359.113
359.114
359.115

Distribution

Distributed nationwide across the United States.

Same manufacturer · Synthes USA HQ, Inc.

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Same hazard · corrosion