CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ recalled
Zimmer Biomet is recalling Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9. The recall was initiated on 30 May 2018 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-2375-2018
- FDA event ID
- 80188
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 May 2018
- FDA classified
- 5 Jul 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 May 2018 | Recall initiated by company | |
| 5 Jul 2018 | Classified by FDA | +36 days |
| 11 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
Product as listed by the FDA
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
Where it was distributed
Products were distributed solely to Japan.
Questions about this recall
Is Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9 recalled?
Yes. Zimmer Biomet recalled Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9 on 30 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2375-2018.
Why was it recalled?
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
Which lots are affected?
62350575 62647167 62787292 63044896 63044897 63068905 63076554 63120523 63161387 63174034
Where was it sold?
Products were distributed solely to Japan.
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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