Biomet, Inc. recalls Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be…
Read the official notice →- Date
- 2022-03-02
- Country
- United States
- Brand
- Biomet
- Product
- Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Ecuador,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Biomet recalls
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The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.
- 2023-02-08
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Biomet, Inc. recalls (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED…
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
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Other drugs & medical recalls in the United States
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Tsm Brands LLC recalls Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC…
Labeling - product contains undeclared ethyl alcohol
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MEDLINE INDUSTRIES, LP - Northfield recalls meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus…
The product was incorrectly shipped at room temperature rather than refrigerated.
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Collagen Matrix, Inc. recalls DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
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