FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
- Recall number
- Z-0583-2014
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
- Status
- Terminated
- Initiated
- 2013-09-30
- Posted
- 2013-12-27
- Terminated
- 2016-10-19
- Reason
- Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
- Root cause
- Device Design
- Action
- Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
- Quantity
- 1,024 units
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- Catalog number 1235-0-014 all lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- 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