FDA Enforcement
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.
Recall: Z-0373-2019
·
Reported November 14, 2018
Enforcement
- Recall Number
- Z-0373-2019
- Event ID
- 81192
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 14, 2018
- Initiation Date
- September 10, 2018
- Classification Date
- November 2, 2018
- Termination Date
- August 31, 2020
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
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
Potential for outer pouch sterile barrier to be compromised
Code Info
Lot SC22130X Exp 2023-08-05
Distribution
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Quantity
15 pouches