FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure.
- Recall number
- Z-1053-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure.
- Status
- Terminated
- Initiated
- 2009-01-30
- Posted
- 2009-04-02
- Terminated
- 2009-12-22
- Reason
- The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
- Root cause
- Labeling design
- Action
- Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.
- Quantity
- 14,613 of all products
- Distribution
- Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
- Lot, serial or model codes
- All lots.
- 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
- 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