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Comprehensive Shoulder System, 4 mm, 122 mm long, Primary… recallZ-1755-2015 · Biomet, Inc. · initiated Apr 16, 2015

Class III Terminated All recalls posted in June 2015

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

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

FDA root cause category: Labeling mix-ups

What the company is doing

Biomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recall details

Recall number
Z-1755-2015
Recall class
Class III
Status
Terminated
Initiated by the company
Apr 16, 2015
Posted by the FDA
Jun 11, 2015
Recalling firm
Biomet, Inc.
Quantity
2
Product code
MBF
FDA submissions
K060692
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

46 devices cleared under K060692 — the recall does not name any of them by identifier. 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 71171).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page