CLASS III Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Comprehensive Shoulder System long, Primary Shoulder Stem recalled

Biomet is recalling Comprehensive Shoulder System long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length, distributed nationwide in the US. The recall was initiated on 16 Apr 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPart Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Quantity recalled2

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-1755-2015
FDA event ID: 71171
Recalling firm: Biomet, Warsaw, IN
Classification: Class III
Status: Terminated
Recall initiated: 16 Apr 2015
FDA classified: 10 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Apr 2015	Recall initiated by company
10 Jun 2015	Classified by FDA	+55 days
17 Jun 2015	Published in enforcement report	+7 days

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

Reason for recall

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Product as listed by the FDA

Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.

Nationwide Alabama Arkansas California Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Carolina New Jersey Nevada Ohio Pennsylvania South Dakota

Questions about this recall

Is Comprehensive Shoulder System long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length recalled?

Yes. Biomet recalled Comprehensive Shoulder System long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length on 16 Apr 2015. The recall is Class III and its status is Terminated. Recall number Z-1755-2015.

Why was it recalled?

Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

Which lots are affected?

Part Numbers: 113644; Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Where was it sold?

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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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