Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedic…

Recall date
September 10, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0373-2019
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.

Why it was recalled

Potential for outer pouch sterile barrier to be compromised

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.

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