Z-2244-2018Class II

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Name: Z-2244-2018 Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Creator: Stryker GmbH
Published: 2018-05-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-05-04 / Terminated

FDA source

Stryker GmbH began a recall of Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 on 2018-05-04. FDA classified it as Class II and gives the reason as "Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2244-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-06-15
Terminated: 2020-04-27
Recalling firm: Stryker Corp.
Product: Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Product code: HXD Clamp
Reason for recall: Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
FDA 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: [email protected], 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 in commerce: 18 parts (10 parts quarantined)
Distribution: AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
Product codes and lots: Lot # 04857V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2244-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-15

Product code HXD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)