Z-1623-2016 Class II Terminated
FDA device recall Z-1623-2016 was initiated by Stanmore Implants Worldwide Ltd. on Apr 12, 2016 and is designated Class II. Reason for recall: Incorrect component used to manufacture distal femoral replacement. The recall status is terminated (terminated Jan 26, 2017). Affected quantity: 1.
Recall details
- Product Type
- Devices
- Report Date
- May 18, 2016
- Initiation Date
- Apr 12, 2016
- Termination Date
- Jan 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product description
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Reason for recall
Incorrect component used to manufacture distal femoral replacement.
Distribution pattern
US distribution to OH.
Code information
Device Identifier: PIN 19960, Lot: 19960
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1623-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026