FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
- Recall number
- Z-1102-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014.
- Status
- Terminated
- Initiated
- 2009-12-30
- Posted
- 2010-03-11
- Terminated
- 2012-09-14
- Reason
- The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.
- Root cause
- Process control
- Action
- Stryker Branches were notified by e-mail on December 30, 2009. This was followed by a formal recall letter by Fed Ex sent on 1/11/10 to branches as well as the hospital and surgeon that used the device.
- Quantity
- 1
- Distribution
- 1 device distributed to a hospital in GA.
- Lot, serial or model codes
- Catalog number: 6276-5-014; Lot number: 20568201, Exp 11/23/2011.
- 510(k) numbers
- ["K013106"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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