FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
- Recall number
- Z-2396-2016
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
- Status
- Terminated
- Initiated
- 2016-07-01
- Posted
- 2016-08-11
- Terminated
- 2017-06-08
- Reason
- Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
- Root cause
- Device Design
- Action
- Stryker notified Branches/Agencies of the Urgent Medical Device Recall by e-mail on July 1, 2016 and an "Urgent Medical Device Recall Letter and Business Reply Form" was sent to branches, agents and hospital risk management via UPS (with return receipt) on July 5, 2016. The letter identified then affected product, problem and actions to be taken. For questions call (201) 831-6693.
- Quantity
- 241 units
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- Catalog No. 0930-9-003
- 510(k) numbers
- ["K110290"]
- 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