Z-2366-2018Class II

Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00

Name: Z-2366-2018 Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00
Creator: Zimmer Biomet, Inc.
Published: 2018-05-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-05-30 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00 on 2018-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2366-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-30
Posted: 2018-07-05
Terminated: 2020-05-28
Recalling firm: Zimmer GmbH
Product: Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: On May 30, 2018, the firm emailed Urgent Medical Device Recall letters to its Japanese subsidiary, who then further distributed the letters locally to Distributors and Risk Managers in Japan. The letter informed affected consignees of the product issue. Customers were instructed to do the following: Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. Request a Return Authorization Number by emailing [email protected]. c. For each return, send a copy of Attachment 1 to [email protected]. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark RECALL on the outside of the returned cartons. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. If you have further questions or concerns after reviewing this information, please call Zimmer Biomet customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call r
Quantity in commerce: 132
Distribution: Products were distributed solely to Japan.
Product codes and lots: 62432961 62848695 62914651 62927105 62927112 63068929 63081264 63090024 63090028 63116798 63161432

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2366-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2362-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2363-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2364-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2365-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2366-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2367-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2368-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2369-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2370-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2371-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2372-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2373-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2374-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05
Z-2375-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-11	2018-07-05

Product code LPH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)