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

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Class IIModerate

FDAJul 22, 2014Nationwide• Zimmer, Inc.

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

Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Class IIModerate

FDA

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

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

Guardian Monitor (Medtronic) – Water Resistance Risk (2014)

Sour Cherry Marmalade (American Spoon) – Potential Mold (2014)

Zenith Slide W-I-D-E Bed (GF Health) – Deck Elevation Problem (2014)

Ground Tuna IQF (Japanese Specialty Food) – Illness Risk (2014)

Fruit-Topped Short Cake (Wegmans) – Produce Contamination (2014)

Fruit Strip Puff Pastry (Wegmans) – Produce Contamination (2014)

Peach Melba Tart (Wegmans) – Produce Contamination (2014)

Fruit-Topped Cheesecake (Wegmans) – Produce Contamination (2014)

Vanilla Trifle (Wegmans) – Produce Contamination (2014)

Sliced Yellow Nectarines (Wegmans) – Produce Contamination (2014)

Peach Salsa (Wegmans) – Produce Contamination (2014)

Sliced Yellow Peaches (Wegmans) – Produce Contamination (2014)

Peach Melba Cream Pie (Wegmans) – Produce Contamination (2014)

Fruit Crostata (Wegmans) – Produce Contamination (2014)

Transpac IV Trifurcated Monitoring Kit w/84" Safeset Rese... (ICU Medical, Inc.) – icu has become aware of an issue with... (2014)

Transpac IT Kit (ICU Medical) – Connection Crack Risk (2014)

X-MARS Set (Gambro) – Connector Breakage (2014)

Single Transpac IT Monitoring Kit w/ (ICU Medical, Inc.) – icu has become aware of an issue with... (2014)