CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Total Knee Replacement recalled by ConforMIS
ConforMIS is recalling Total Knee Replacement, distributed in California, Texas. The recall was initiated on 24 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0600-2018
- FDA event ID
- 78902
- Recalling firm
- ConforMIS, Bedford, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2017
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +204 days |
| 21 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Implant kit mislabeled
Product as listed by the FDA
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Where it was distributed
US Distribution to the states of :CA and TX.
Questions about this recall
Why was it recalled?
Implant kit mislabeled
Which lots are affected?
Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
Where was it sold?
US Distribution to the states of :CA and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ConforMIS
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|---|---|---|---|---|---|
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