CLASS II Device recall · Reported 15 Nov 2017 · FDA Enforcement Report
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee recalled
Zimmer Biomet is recalling Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. The recall was initiated on 25 Apr 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-0070-2018
- FDA event ID
- 78299
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2017
- FDA classified
- 8 Nov 2017
- Reported
- 15 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 25 Apr 2017 | Recall initiated by company | |
| 8 Nov 2017 | Classified by FDA | +197 days |
| 15 Nov 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
Product as listed by the FDA
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Where it was distributed
This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
Questions about this recall
Is Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee recalled?
Yes. Zimmer Biomet recalled Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee on 25 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-0070-2018.
Why was it recalled?
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
Which lots are affected?
Part Number: CP116574 Lot Number: 073840
Where was it sold?
This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
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