Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 ...
FDA Device Recall #Z-1169-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-1169-2016 |
| 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 |
| Quantity | 2388 |
Product Description
Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ 783401500 VERSYS PRESS FIT LD/FX SZ 783401600 VERSYS PRESS FIT LD/FX SZ 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.: 62141788 62194578 62284482 62284482N 61870886 61885906 61952556 61952557 62024629 62065277 62076884 62097070 62125314 62147327 62167372 62193417 62194579 62221879 62270707 62298289 62310428 62340081 62360302 61886895 61953169 62036899 62046493 62055999 62065278 62097073 62106807 62125315 62127736 62141792 62151830 62167373 62183148 62194580 62208755 62210445 62291930 62310435 62324097 62333971 62340080 62358910 62362926 61881190 61890332 61953170 61964733 62033228 62056001 62073507 62076886 62080036 62080037 62097076 62106804 62137224 62141789 62147328 62151832 62165198 62165199 62178286 62181429 62183150 62204531 62207225 62208757 62210446 62270709 62291929 62310430 62310432 62320165 62333970 62340077 62340078 62345388 62345389 62354664 62358904 62358905 61873652 61882614 61885902 61885904 61891301 61969293 62033229 62042592 62052831 62060680 62097077 62100687 62106802 62106803 62137225 62141790 62165201 62165202 62183149 62203186 62210447 62215710 62227046 62240749 62240750 62291931 62312488 62324096 62333976 62333978 62358908 62358909 61834957 61878471 61952559 61957434 61964735 62017573 62033230 62073508 62076888 62100688 62106805 62133327 62141791 62161482 62181430 62203187 62218181 62240751 62270711 62298290 62325574 62340079 61864115 62033231 62056002 62076889 62106806 62137226 62165203 62194581 62218180 62312489 62340082 62358903
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.