FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Restoration Modular Hip System; Proximal Cone Body; 25 mm +20 mm; Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
- Recall number
- Z-2173-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Restoration Modular Hip System; Proximal Cone Body; 25 mm +20 mm; Not for use with + 16 V40 femoral Head. For Cementless Use Only. Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss.
- Status
- Terminated
- Initiated
- 2009-06-26
- Posted
- 2009-09-14
- Terminated
- 2010-07-27
- Reason
- The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St
- Root cause
- Nonconforming Material/Component
- Action
- Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
- Quantity
- 203 - all varieties
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog number: 6276-1-225; REST MOD PROX CONE BODY 25mm +20 28932602 25-Feb-2014 REST MOD PROX CONE BODY 25mm +20 28891201 19-Feb-2014 REST MOD PROX CONE BODY 25mm +20 28932602 25-Feb-2014 REST MOD PROX CONE BODY 25mm +20 28932601 16-Mar-2014 REST MOD PROX CONE BODY 25mm +20 28932601 16-Mar-2014 REST MOD PROX CONE BODY 25mm +20 28932601 16-Mar-2014
- 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
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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