Recall Z-0684-2016 — TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
U.S. FDA — Device Enforcement · United States · 2015-11-25 · Class II
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Reported risk: The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
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