Reported Feb 22, 2017 · Terminated
Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty…
Greatbatch Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575
Is this the product you have?
- Offset Reamer Handle
- T5766 Product UsageThe 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 intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel¿ tube and outer housing
- Lot codes and dates
24811932468380259978524633092468379246839824683972599516267155525995172670543267155827348092814828281482928244962858434286540430306582944397297785229672143000586300059030306583044689307190331356583088675310750431886883385844318869033870463397768
- Amount recalled
- 1,441
Where it was sold
- Nationwide
- IN
Why it was recalled
On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.
This product could cause temporary or reversible health problems — stop using it.
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