FDA Medical Device Recalls (openFDA)
Stryker GmbH: Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
- Recall number
- Z-2244-2018
- Recalling firm
- Stryker GmbH
- Product
- Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
- Status
- Terminated
- Initiated
- 2018-05-04
- Posted
- not on file
- Terminated
- 2020-04-27
- Reason
- Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
- Root cause
- Other
- Action
- On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. b) If you are a Distributor, note that you are responsible for notifying your affected customers. Customers with questions may call 201-831-5000.
- Quantity
- 18 parts (10 parts quarantined)
- Distribution
- AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
- Lot, serial or model codes
- Lot # 04857V
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXD
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
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