Zimmer Biomet, Inc.: Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

Recall number

Z-2362-2018

Recalling firm

Zimmer Biomet, Inc.

Product

Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10

Status

Terminated

Initiated

2018-05-30

Posted

not on file

Terminated

2020-05-28

Reason

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

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 CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com. c. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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

294

Distribution

Products were distributed solely to Japan.

Lot, serial or model codes

62107667 62410983 62410984 62445410 62449677 62450635 62469393 62478848 62478852 62478855 62503181 62547038 62554172 62559999 62560152 62577929 62630007 62636746 62652981 62659334 62667678 62753395 62770876 62777941 62791158 62806022 62897465

510(k) numbers

not on file

PMA numbers

not on file

Product code

LPH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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