Z-1905-2018 Class II Terminated
FDA device recall Z-1905-2018 was initiated by Smith & Nephew, Inc. on Mar 30, 2018 and is designated Class II. Reason for recall: The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch. The recall status is terminated (terminated Aug 21, 2019). Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Mar 30, 2018
- Termination Date
- Aug 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
Product Description
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Reason for Recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Distribution Pattern
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Code Information
Batch Numbers: 09FM04561; 14AM05774 & 15GM11501
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1905-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026