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Acumatch Bipolar Liner (Exactech) – Packaging Layer (2024)

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

Low

FDAApr 26, 2024IN, PR• Exactech, Inc.

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Class IIModerate

FDAApr 26, 2024Nationwide• Rubicon Research Private Limited

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Acumatch Bipolar Liner (Exactech) – Packaging Layer (2024)

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Gibson Farms Organic Nuts (Gibson Farms) – E. Coli Risk (2024)

StarDrive Screwdriver (Synthes) – Tip Engagement (2024)

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Crustless Chicken Potato Pot Pie (Nutrition Corp) – Listeria Risk (2024)

OXINIUM Femoral Head (Smith & Nephew) – Size Mismatch (2024)

EsophaCap (Lucid Diagnostics) – Sponge Detachment (2024)

EasySuite 4K Operating Room System (Olympus) – Testing Records (2024)

Haloperidol Injection (Somerset) – Foreign Substance (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Clorazepate Tablets (Aurobindo) – Tablet Discoloration (2024)

Cascade IOMAX Cortical Module (Cadwell) – Insulator Risk (2024)

Trevo XP ProVue Retriever (Stryker) – Endotoxin Testing (2024)

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SURGIFOAM Gelatin Powder Kit (Ethicon) – Applicator Seal (2024)

IMMULITE 2000 Anti-TG Ab (Siemens) – Result Elevation (2024)