Agency classClass IIOur severity:High FDA (Devices)·Z-0442-2019·Announced 2018-11-21

Arthrex Recalls 3.2mm Proximal Reamer Due to Potential Breakage During Use

Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.

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 is classified as FDA Class II, and the hazard involves a medical device that may break during use, posing a risk of harm to patients, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill, which is provided as part of the Fibulock Fibular Nail System Pack. The recall is being conducted because there is a potential for the instrument to break during use.

The affected product is part of the FibuLock Nail Procedure Pack, which contains instrumentation for the implantation of the FibuLock implant. The specific part number is ST6100. The recall covers specific lot and serial numbers, including A251217-04, A011217-01, and A011217-03, among others.

The product was distributed throughout the United States to 31 states, including North Carolina, California, New Jersey, Colorado, Nevada, Utah, Louisiana, Kentucky, Ohio, Arizona, Missouri, Minnesota, Tennessee, New York, Wisconsin, Massachusetts, Pennsylvania, Texas, Illinois, Arkansas, Florida, Iowa, Michigan, Alabama, South Dakota, Oregon, Washington, Maryland, Kansas, and Georgia. Users should stop using the affected instruments and contact Arthrex, Inc. for instructions on return or replacement.

The recalled product

Product: 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill…
Manufacturer: Arthrex, Inc.
Category: Medical Device — Surgical Instrument
Hazard: breakage
Affected units: 832

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 (20)

Part #ST6100
Lot/Serial #'s: A251217-04
A011217-01
A011217-03
A091017-05
A101017-01
A111017-01
A121017-01
A121017-02
A131017-01
A140917-01
A161017-01
A171017-01
A181017-07
A221117-01
A271117-01
A281117-02
A291117-01
A291117-03
A301117-01

Distribution

Distributed in 30 states:

Same manufacturer · Arthrex, Inc.

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Same hazard · breakage