Z-0200-2019 Class II Terminated
FDA device recall Z-0200-2019 was initiated by Smith & Nephew, Inc. on Sep 18, 2018 and is designated Class II. Reason for recall: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. The recall status is terminated (terminated May 8, 2019). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Sep 18, 2018
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
Reason for Recall
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Distribution Pattern
US Distribution to the states of: KS and TN.
Code Information
Lot 17LM05396
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0200-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026