FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
- Recall number
- Z-2365-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 10; 00-7713-010-00
- Status
- Terminated
- Initiated
- 2018-05-30
- Posted
- not on file
- Terminated
- 2020-05-28
- Reason
- not on file
- 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
- 24
- Distribution
- Products were distributed solely to Japan.
- Lot, serial or model codes
- 62361460 62528141
- 510(k) numbers
- ["K063251"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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