Z-2163-2018 Class II Terminated
FDA device recall Z-2163-2018 was initiated by Smith & Nephew, Inc. on May 4, 2018 and is designated Class II. Reason for recall: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. The recall status is terminated (terminated Feb 22, 2019). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 20, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- Feb 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Reason for Recall
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Distribution Pattern
International only: United Arab Emirates, Spain, Mexico
Code Information
15FM16181
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2163-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026