Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM S...
FDA Device Recall #Z-1155-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-1155-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Manufacturing B.V. |
| Location | Mercedita, PR |
| Product Type | Devices |
Product Description
Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty
Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
lot no.: 62012579 62086025 62086025N 62055993 62264285 62362923 62264285N 62151833 62284483 62362921 62284483N 62224932 62284484 62340084 61886896 62043474 62141793 62284485 62362930 62284485N 62240754 62293494
Other Recalls from Zimmer Manufacturing B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1677-2016 | Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancell... | May 4, 2016 |
| Z-1678-2016 | Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Co... | May 4, 2016 |
| Z-1684-2016 | Class II | Trilogy self-tapping bone screw Bone screw 4.... | May 4, 2016 |
| Z-1676-2016 | Class II | Periarticular plating system, cancellous bone s... | May 4, 2016 |
| Z-1681-2016 | Class II | ITST intertrochanteric/subtrochanteric fixati... | May 4, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.