PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 14, 2018 Initiated: September 10, 2018 #Z-0373-2019

Product Description

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.

Reason for Recall

Potential for outer pouch sterile barrier to be compromised

Details

Recalling Firm
Howmedica Osteonics Corp.
Units Affected
15 pouches
Distribution
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Location
Mahwah, NJ

Frequently Asked Questions

What product 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.. Recalled by Howmedica Osteonics Corp.. Units affected: 15 pouches.
Why was this product recalled?
Potential for outer pouch sterile barrier to be compromised
Which agency issued this recall?
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0373-2019.