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Recall Observatory FDA recall evidence

Device product

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.

Z-2600-2016

July 21, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 74855
Status
Terminated
Classification
Class II
Quantity
120 units from multiple lots
Official record key
device-enforcement:Z-2600-2016

Official wording

Reason: Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".

Code information: Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".