medical Class II Updated 2019-11-20

Orthofix Srl recalls ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE K

Recalled Product

ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18054242510888

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 # B1202055, B1225324, B1225854, B1226694, B1228037, B1228211, B1228361, B1228547, B1231459
View official government recall

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