medical Class II Updated 2019-11-20

Orthofix Srl recalls ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER MET

Recalled Product

ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696

Hazard / Issue

As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.

Issued by

FDA

Affected States: AZ, CA, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV
Lot/Code Info: Lot # B1207402, B1209817, B1211407, B1212676, B1229618, B1232423, B1233324, B1233663
View official government recall

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