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Exactech, Inc. Recall: Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73,

Exactech, Inc. Recall: Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Exactech, Inc.; Product: Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.; Reason for recall: There is a design inc

Recalling firmExactech, Inc.
ProductOptetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Reason for recallThere is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionDistribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Recall initiated20170919
Recall numberZ-0149-2018
Categorydevice
StateFL
CountryUnited States

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