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Comprehensive Shoulder System recallZ-0980-2018 · Zimmer Biomet, Inc. · initiated Dec 8, 2017

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0980-2018
Status
Terminated
Initiated by the company
Dec 8, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
12
Product code
HSD
FDA submissions
K060692
Distribution
US Nationwide in the states of MN, NJ, CA, TX, ND

Product description

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

Code information (models, lots, serial numbers)

PN: 113617, LN: 552850, UDI# - (01) 00880304554184 (17) 271014 (10) 552850

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

45 devices cleared under K060692 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 79385).

Sources and updates

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