FDA-Device2018-11-14Class II

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.

Howmedica Osteonics Corp.
Hazard

Potential for outer pouch sterile barrier to be compromised

Sold states
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Affected count
15 pouches
Manufactured in
325 Corporate Dr, Mahwah, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0373-2019

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