FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
- Recall number
- Z-1239-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
- Status
- Terminated
- Initiated
- 2018-01-24
- Posted
- 2018-03-14
- Terminated
- 2019-04-09
- Reason
- One lot of humeral stem implants do not include the humeral bushing components.
- Root cause
- Under Investigation by firm
- Action
- 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.
- Quantity
- 9
- Distribution
- Distributed in China and Taiwan.
- Lot, serial or model codes
- Lot Number: 63694912
- 510(k) numbers
- ["K001989"]
- PMA numbers
- not on file
- Product code
- JDC
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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