Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instrume...
FDA Device Recall #Z-1190-2017 — Class II — October 19, 2016
Recall Summary
| Recall Number | Z-1190-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 19, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Greatbatch Medical |
| Location | Plymouth, MN |
| Product Type | Devices |
| Quantity | 1,441 |
Product Description
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 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of IN and the countries of Canada, Austria, Germany, Japan.
Lot / Code Information
2481193, 2468380, 2599785, 2463309, 2468379, 2468398, 2468397, 2599516, 2671555, 2599517, 2670543, 2671558, 2734809, 2814828, 2814829, 2824496, 2858434, 2865404, 3030658, 2944397, 2977852, 2967214, 3000586, 3000590, 3030658, 3044689, 3071903, 3135658, 3088675, 3107504, 3188688, 3385844, 3188690, 3387046, 3397768.
Other Recalls from Greatbatch Medical
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2055-2017 | Class II | Linear Straight Broach Handle (Rasp Handle) (Gr... | Apr 23, 2017 |
| Z-2782-2017 | Class II | Biosense Webster MobiCath Bi-Directional Guidin... | Feb 15, 2017 |
| Z-2781-2017 | Class II | ViaPeel PTFE Peelable Introducer 5FR, Part Numb... | Nov 11, 2016 |
| Z-0623-2017 | Class II | Greatbatch Stiffer Coaxial Micro-Introducer. Mo... | Sep 8, 2016 |
| Z-0367-2017 | Class I | Greatbatch, Offset Cup Impactor with the follow... | Aug 2, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.