Recalls / —

—#164807

Product

Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00

FDA product code

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K063251

Affected lot / code info

62361460 62528141

Why it was recalled

—

Root cause (FDA determination)

Packaging

Action the firm took

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

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

Products were distributed solely to Japan.

Timeline

Recall initiated

2018-05-30

Terminated

2020-05-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #164807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.