Z-0373-2019 Class II Terminated
FDA device recall Z-0373-2019 was initiated by Howmedica Osteonics Corp. on Sep 10, 2018 and is designated Class II. Reason for recall: Potential for outer pouch sterile barrier to be compromised The recall status is terminated (terminated Aug 31, 2020). Affected quantity: 15 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Sep 10, 2018
- Termination Date
- Aug 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 pouches
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
Distribution Pattern
US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Code Information
Lot SC22130X Exp 2023-08-05
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0373-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026