Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
FDA Recall Z-2600-2016 · Posted None
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2016-07-21
Date Terminated2017-03-29
Product Quantity120 units from multiple lots
Reason for Recall
Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
Firm Action
Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to [email protected] or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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