Device product
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.
Z-0373-2019
Product summary
- Event
- Event 81192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 pouches
- Official record key
device-enforcement:Z-0373-2019
Official wording
Reason: Potential for outer pouch sterile barrier to be compromised
Code information: Lot SC22130X Exp 2023-08-05
Distribution pattern: US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Derived failure modes
-
Sterility assurance
sterile barrier to be compromised