Device recall: ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US)…
Class II FDA enforcement event 72108. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
May contain small amounts of ethylene glycol residue
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
ConforMIS, Inc. started this device recall on 31 Aug 2015. The firm address in the FDA record is in Bedford, MA. FDA put the recall in Class II. FDA event 72108 has 11 product records. The first FDA enforcement report date is 28 Oct 2015. The record gives the status Terminated, with the termination date 2 Mar 2016.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed Nationwide and in Germany, Switzerland, and UK.
Recalling firm
ConforMIS, Inc., Bedford, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0138-2016 | ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS) | 7 units | Class II | Terminated | 28 Oct 2015 |
| Z-0139-2016 | ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS) | 71 units | Class II | Terminated | 28 Oct 2015 |
| Z-0140-2016 | ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS) | 6 units | Class II | Terminated | 28 Oct 2015 |
| Z-0141-2016 | ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS) | 68 units | Class II | Terminated | 28 Oct 2015 |
| Z-0142-2016 | ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230 | N/A | Class II | Terminated | 28 Oct 2015 |
| Z-0143-2016 | ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS) | 12 units | Class II | Terminated | 28 Oct 2015 |
| Z-0144-2016 | ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111 | 3 units | Class II | Terminated | 28 Oct 2015 |
| Z-0145-2016 | ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS) | 313 units | Class II | Terminated | 28 Oct 2015 |
| Z-0146-2016 | ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS) | 348 units | Class II | Terminated | 28 Oct 2015 |
| Z-0147-2016 | ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111 | 110 units | Class II | Terminated | 28 Oct 2015 |
| Z-0148-2016 | ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS) | 1 unit | Class II | Terminated | 28 Oct 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 21
Other events of the firm
Official channels
- FDA enforcement report Z-0138-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 72108. https://recallregister.com/fda/ii/72108/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed Nationwide and in Germany, Switzerland, and UK.
- What quantity of product is in FDA event 72108?
- The event has 11 product records. The first record gives this quantity:
7 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.