ConFormis iTotal Posterior Stabilized Knee Replacement… recallZ-0147-2016 · ConforMIS, Inc. · initiated Aug 31, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConforMIS, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
May contain small amounts of ethylene glycol residue
FDA root cause category: Process design
What the company is doing
ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.
Recall details
- Recall number
- Z-0147-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 31, 2015
- Posted by the FDA
- Oct 21, 2015
- Recalling firm
- ConforMIS, Inc.
- Quantity
- 110 units
- Product code
- JWH
- FDA submissions
- K142161, K142404
- Distribution
- Distributed Nationwide and in Germany, Switzerland, and UK.
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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 devices under the same FDA submission
5 devices cleared under K142161, K142404 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR111111102Conformis, Inc. · Knee Arthroplasty Implantation System390 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- iTotal® CR iPoly™ Insert Kit RCR010000B03Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- iTotal® CR iPoly™ Insert Kit RCR010080003Conformis, Inc. · Knee Arthroplasty Implantation System1 report
- iTotal® PS iPoly™ Insert Kit RPS010140001Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 72108).
- Z-0141-2016 · TerminatedConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
- Z-0142-2016 · TerminatedConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
- Z-0143-2016 · TerminatedConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
- Z-0144-2016 · TerminatedConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
- Z-0145-2016 · TerminatedConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
- Z-0146-2016 · TerminatedConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
- Z-0148-2016 · TerminatedConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page