The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker Sy...
FDA Device Recall #Z-1127-2013 — Class II — March 14, 2013
Recall Summary
| Recall Number | Z-1127-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synvasive Technology Inc |
| Location | El Dorado Hills, CA |
| Product Type | Devices |
| Quantity | 100 kits |
Product Description
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Reason for Recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Distribution Pattern
USA Nationwide Distributor including the state of IN
Lot / Code Information
Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Other Recalls from Synvasive Technology Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1676-2020 | Class II | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19... | Jul 27, 2018 |
| Z-0466-2016 | Class II | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19... | Dec 8, 2015 |
| Z-1115-2013 | Class II | Product is distributed by Zimmer (Warsaw, India... | Apr 2, 2013 |
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.