Data Foundry

Medical device recalls 2018

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless — Class II medical device recall Z-2363-2018

Terminated recall by Zimmer Biomet, Inc., reported 2018-07-11. M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2

Recall numberZ-2363-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer Biomet, Inc., Warsaw, IN, United States
Recall initiated2018-05-30
Classified2018-07-05
Reported by FDA2018-07-11
Terminated2020-05-28
Countries outside the USJP
Quantity227

Product

Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2363-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.