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Double Offset Rasp Handle (Zimmer) – Handle Assembly Failure (2014)

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Class IIModerate

FDAJul 23, 2014Nationwide• Zimmer, Inc.

Peachy Keen Cold Pressed (Whole Foods Market) – Listeria risk (2014)

Listeria

The product has the potential to be contaminated with Listeria monocytogenes.

Class IIModerate

FDAJul 23, 2014Nationwide

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Double Offset Rasp Handle (Zimmer) – Handle Assembly Failure (2014)

Peachy Keen Cold Pressed (Whole Foods Market) – Listeria risk (2014)

Double Offset Rasp Handle (Zimmer) – Handle Assembly Failure (2014)

Peaches, Feta with Toasted Almonds (Whole Foods) – Listeria contamination (2014)

VER2 Handle Pin Rework (Zimmer) – Handle Assembly Failure (2014)

Cancellous Screw (Zimmer) – Leak Test Failure (2014)

Malleolar Screw (Zimmer) – Leak Test Failure (2014)

Endo Femoral Heads (Zimmer) – Packaging Verification (2014)

Trauma Tubes and Plates (Zimmer) – Packaging Verification (2014)

Knee Stem Extensions (Zimmer) – Packaging Verification (2014)

Trauma Large Screws (Zimmer) – Packaging Verification (2014)

Cancellous Screw (Zimmer) – Leak Test Failure (2014)

Knee Instrument Fixation Screws (Zimmer) – Packaging Verification (2014)

Endo Femoral Heads (Zimmer) – Packaging Verification (2014)

Magna-Fx Cannulated Screw (Zimmer) – Leak Test Failure (2014)

ICT Serum Calibrator (Abbott) – Potassium QC Issue (2014)

Moore & Thompson Hip Stems (Zimmer) – Packaging Verification (2014)

Cancellous Screw (Zimmer) – Leak Test Failure (2014)

PosiFlush SF Saline Syringe (Becton Dickinson) – Open Seal Risk (2014)

Magna-Fx Cannulated Screw (Zimmer) – Leak Test Failure (2014)