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Showing 22581–22600 of 29086 results

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Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Temporomandibular Joint Replacement (Biomet) – Laser Etching Depth (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Tenaxis ArterX Surgical Sealant (Mallinckrodt) – Improper Labeling (2014)

Product was improperly labeled leading to improper storage.

Class IIModerate

FDAOct 17, 2014Nationwide• Mallinckrodt Manufacturing LLC

Cardiohelp-I System (Maquet) – Battery Message Error (2014)

Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power

Class IIModerate

FDAOct 17, 2014Nationwide• Maquet Cardiovascular Us Sales, Llc

Temporomandibular Joint Replacement (Biomet) – Laser Etching Depth (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Legionella BCYE Supplement (Remel) – Recovery Limitation (2014)

Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.

Class IIModerate

FDAOct 17, 2014IN, ND, TX +1 more• Remel Inc

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Obagi Nu-Derm Clear (Obagi Medical) – Labeling Mix-Up (2014)

Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.

Class IIModerate

FDAOct 17, 2014Nationwide• Obagi Medical Products

PERMA-HAND Silk Suture (Ethicon) – Sterility Assurance (2014)

Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Class IIModerate

FDAOct 17, 2014Nationwide• Ethicon, Inc.

INOMAX DSIR System (INO Therapeutics) – Concentration Reporting (2014)

An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.

Class IIModerate

FDAOct 17, 2014IN, PA, VA• INO Therapeutics (dba Ikaria)

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Temporomandibular Joint Replacement (Biomet) – Laser Etching Depth (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Temporomandibular Joint Replacement (Biomet) – Laser Etching Depth (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Total Temporomandibular Joint Replacement (Biomet) - Laser Etching Issue (2014)

Laser etching on the parts is wider and deeper than the conditions previously validated.

Class IIModerate

FDAOct 17, 2014CA, MN, PA• Biomet Microfixation, LLC

Gabapentin Capsules (Aurobindo Pharma) – Empty Capsules (2014)

Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Class IIModerate

FDAOct 17, 2014Nationwide• Aurobindo Pharma USA Inc

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