CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

Comprehensive Shoulder System Mini Humeral Stem recalled by Biomet

Biomet is recalling Comprehensive Shoulder System Mini Humeral Stem, distributed nationwide in the US. The recall was initiated on 17 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260
Quantity recalled14 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1543-2020
FDA event ID
85073
Recalling firm
Biomet, Warsaw, IN
Classification
Class II
Status
Terminated
Recall initiated
17 Feb 2020
FDA classified
20 Mar 2020
Reported
1 Apr 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

17 Feb 2020Recall initiated by company
20 Mar 2020Classified by FDA+32 days
1 Apr 2020Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Nationwide

Questions about this recall

Is Comprehensive Shoulder System Mini Humeral Stem recalled?

Yes. Biomet recalled Comprehensive Shoulder System Mini Humeral Stem on 17 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1543-2020.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

International distribution in the countries of Canada, Japan, Netherlands, South Korea.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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