Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1190-2017·Announced 2017-02-22

Greatbatch Recalls T5766 Offset Reamer Handles Due to Drive Chain Seizure

Greatbatch Medical is recalling 1,441 T5766 Offset Reamer Handles because the drive chain U-joints may seize during hip surgery, rendering the device non-functional.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a device malfunction (seizure) that renders the instrument non-functional during surgery, but the source text does not report any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Greatbatch Medical is recalling 1,441 units of the T5766 Offset Reamer Handle. These are reusable surgical instruments used in hip arthroplasty procedures, such as total joint replacement or resurfacing surgery. The handles are intended to be used with a surgical driver and connect to a reamer cutting instrument.

The recall was initiated after Greatbatch discovered a significant increase in field complaints in June 2016. The complaints indicated that the U-joints of the drive chain component were seizing during orthopedic procedures, which rendered the device non-functional. The company noted that the 2016 failure rate for this specific issue exceeded the occurrence rate defined in the device's Design Failure Mode and Effects Analysis (DFMEA).

The affected units were distributed worldwide, including nationwide in the United States (specifically Indiana) and in Canada, Austria, Germany, and Japan. Healthcare providers and facilities should stop using the affected reamer handles and contact Greatbatch Medical for further instructions on the recall.

The recalled product

Product: Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are…
Manufacturer: Greatbatch Medical
Category: Medical Device — Surgical Instrument
Hazard: device-malfunction
Affected units: 1,441

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)

2481193
2468380
2599785
2463309
2468379
2468398
2468397
2599516
2671555
2599517
2670543
2671558
2734809
2814828
2814829
2824496
2858434
2865404
3030658
2944397

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Greatbatch Medical

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