FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
- Recall number
- Z-1601-2010
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
- Status
- Terminated
- Initiated
- 2010-03-29
- Posted
- 2010-05-13
- Terminated
- 2012-09-10
- Reason
- Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.
- Root cause
- Error in labeling
- Action
- Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.
- Quantity
- 24 units
- Distribution
- Nationwide Distribution -- FL, MN, & OR.
- Lot, serial or model codes
- Lot code - L3988
- 510(k) numbers
- ["K974054"]
- PMA numbers
- not on file
- Product code
- JDI
- 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