CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report

Farabeuf Clamp for Screws PRO recalled by Stryker

Stryker is recalling Farabeuf Clamp for Screws PRO, distributed in 11 states. The recall was initiated on 4 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 04857V

Quantity recalled18 parts (10 parts quarantined)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2244-2018
FDA event ID: 80198
Recalling firm: Stryker, Selzach, N/A
Classification: Class II
Status: Terminated
Recall initiated: 4 May 2018
FDA classified: 15 Jun 2018
Reported: 27 Jun 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 May 2018	Recall initiated by company
15 Jun 2018	Classified by FDA	+42 days
27 Jun 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463

Where it was distributed

AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX

Arkansas California Idaho Illinois Maryland Michigan New Jersey New York Oklahoma South Dakota Texas

Questions about this recall

Is Farabeuf Clamp for Screws PRO recalled?

Yes. Stryker recalled Farabeuf Clamp for Screws PRO on 4 May 2018. The recall is Class II and its status is Terminated. Recall number Z-2244-2018.

Why was it recalled?

Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm

Which lots are affected?

Lot # 04857V

Where was it sold?

AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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