Z-0822-2017 Class II Terminated
FDA device recall Z-0822-2017 was initiated by Stanmore Implants Worldwide Ltd. on Dec 7, 2016 and is designated Class II. Reason for recall: The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. The recall status is terminated (terminated Jul 17, 2017). Affected quantity: 11 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Dec 7, 2016
- Termination Date
- Jul 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units
Product description
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Reason for recall
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Distribution pattern
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
Code information
B10191, B10443, B9920, B10561, B9921, B9922
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0822-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026