Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT ...
FDA Device Recall #Z-1255-2014 — Class II — February 25, 2014
Recall Summary
| Recall Number | Z-1255-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 3638 units |
Product Description
Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM
Reason for Recall
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Lot / Code Information
Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0981-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0973-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0977-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0967-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
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.