—#162190

Product

Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

FDA product code: HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060692
Affected lot / code info: PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide in the states of MN, NJ, CA, TX, ND

Timeline

Recall initiated: 2017-12-08
Terminated: 2018-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162190. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.