ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEF...
FDA Device Recall #Z-0147-2016 — Class II — August 31, 2015
Recall Summary
| Recall Number | Z-0147-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 31, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ConforMIS, Inc. |
| Location | Bedford, MA |
| Product Type | Devices |
| Quantity | 110 units |
Product Description
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Reason for Recall
May contain small amounts of ethylene glycol residue
Distribution Pattern
Distributed Nationwide and in Germany, Switzerland, and UK.
Lot / Code Information
Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269 Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247 Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
Other Recalls from ConforMIS, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1591-2024 | Class II | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | Mar 11, 2024 |
| Z-2405-2023 | Class II | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | Jun 16, 2023 |
| Z-1133-2023 | Class II | iTotal Identity Impactor Handle, Model No. 1080... | Nov 14, 2022 |
| Z-0899-2022 | Class II | iTotal Identity Posterior Stabilised (PS) Knee ... | Feb 22, 2022 |
| Z-0475-2021 | Class II | iTotal Hip Replacement System, Model number HAA... | Sep 21, 2020 |
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.