Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Recall Z-0979-2018 · Posted None
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Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHSD
Date Initiated2017-12-08
Date Terminated2018-09-04
Product Quantity12
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.
Firm Action
On December 13, 2017 an URGENT MEDICAL DEVICE RECALL letter was issued to customers notifying them of the mix-up and requesting that they review the notification, discuss with team members, see if any product is in inventory and if so, quarantine and discontinue use. Affected product should be returned to the recalling firm. Questions or concerns can be directed to customer service at 574-371-3071.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide in the states of MN, NJ, CA, TX, ND
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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