FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.
- Recall number
- Z-0275-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Zimmer, Warsaw, IN, 46581-0708.
- Status
- Terminated
- Initiated
- 2007-09-26
- Posted
- 2007-11-29
- Terminated
- 2008-06-04
- Reason
- Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
- Root cause
- Packaging process control
- Action
- Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
- Quantity
- 1
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot 2376766.
- 510(k) numbers
- ["K070292"]
- PMA numbers
- not on file
- Product code
- KXA
- 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