FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
- Recall number
- Z-0619-2011
- Recalling firm
- Zimmer Inc.
- Product
- Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057, Zimmer, Warsaw, IN.
- Status
- Terminated
- Initiated
- 2010-11-15
- Posted
- 2010-12-14
- Terminated
- 2011-05-23
- Reason
- Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.
- Root cause
- Employee error
- Action
- Zimmer contacted the two affected accounts directly by phone on November 15, 2010 to inform them of the recall. Zimmer will monitor the return of the affected instruments and account for the outstanding instruments until the removal action is complete. Each of the affected accounts will be provided with a new trial insert, manufactured and packaged with the correct component. The accounts will be asked to return the affected units back to Zimmer where the returned product will be destroyed. Customers can contact Zimmer at 574 371-8852 concerning this recall.
- Quantity
- 3
- Distribution
- Worldwide Distribution: US in the states of KS and UT, and the country of Canada.
- Lot, serial or model codes
- 61438482
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- 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