FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants. Stryker Orthopaedics. Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
- Recall number
- Z-2144-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants. Stryker Orthopaedics. Indicated for use in partial hip replacement procedures for patients suffering from pain and disability due to a variety of related bone disease.
- 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
- 24
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog number: 570-000-01: CORIN UNIPOLAR ADAPTOR SLEEVE JW3MHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE JXNMHE 25-Apr-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DHMJE 17-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DKMJE 19-May-2013 CORIN UNIPOLAR ADAPTOR SLEEVE 8DVMJE 21-May-2013
- 510(k) numbers
- ["K071471"]
- PMA numbers
- not on file
- Product code
- KWL
- 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