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Comprehensive Shoulder System recallZ-1543-2020 · Biomet, Inc. · initiated Feb 17, 2020

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 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

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

FDA root cause category: Under Investigation by firm

What the company is doing

URGENT MEDICAL DEVICE FIELD SAFETY NOTICE-REMOVAL letter dated February 17, 2020 was sent via email to consignees. The letter identified affected product, problem and the action to be taken. Customers were advised to take the following actions: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4.Complete Attachment 1 Certification of Acknowledgement Form and send to [email protected] form must be returned even if you do not have affected products available to return in your facility. 5.Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing [email protected].

Recall details

Recall number
Z-1543-2020
Status
Terminated
Initiated by the company
Feb 17, 2020
Posted by the FDA
Mar 3, 2020
Recalling firm
Biomet, Inc.
Quantity
14 units
Product code
MBF
FDA submissions
K060692
Distribution
International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Product description

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

Code information (models, lots, serial numbers)

Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260

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.

Sources and updates

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