(b)(4).Medical device lot number - complainant provided a lot number, however, it was discovered to not be valid for this item.Concomitant medical products: cortical screw 3.5 x 60mm catalog# 815037060; cortical screw 3.5 x 50mm catalog# 815037050; fibula comp lock plate 8h catalog# 816204008; 4.0mm canc lock screw 14mm catalog# 816140014; 4.0mm canc lock screw 12mm catalog# 816140012; 4.0mm canc lock screw 24mm catalog# 815037024.User facility has indicated that the product is available for evaluation, however, has not responded to requests of product return.Once the investigation has been completed, a follow-up mdr will be submitted.[(b)(4)].
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