Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder ar...
FDA Recall #Z-0979-2018 — Class II — December 8, 2017
Product Description
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Reason for Recall
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
Recalling Firm
Zimmer Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
12
Distribution
US Nationwide in the states of MN, NJ, CA, TX, ND
Code Information
PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.