—#148608

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.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071639
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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 FCA1@integralife.com 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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

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

Timeline

Recall initiated: 2016-07-21
Terminated: 2017-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.