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U.S. Department of Health and Human Services

Class 2 Device Recall Farabeuf Clamp for 3.5mm Screws PRO

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  Class 2 Device Recall Farabeuf Clamp for 3.5mm Screws PRO see related information
Date Initiated by Firm May 04, 2018
Create Date June 15, 2018
Recall Status1 Terminated 3 on April 27, 2020
Recall Number Z-2244-2018
Recall Event ID 80198
Product Classification Clamp - Product Code HXD
Product Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Code Information Lot # 04857V
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Aminah Crawford
201-831-5272
Manufacturer 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 Determined
Cause 2		 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 in Commerce 18 parts (10 parts quarantined)
Distribution AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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