Z-2534-2016 Class II Terminated
FDA device recall Z-2534-2016 was initiated by Straumann Manufacturing, Inc. on July 14, 2016 and is designated Class II. Reason for recall: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration The recall status is terminated (terminated November 20, 2020). Affected quantity: 70 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- July 14, 2016
- Termination Date
- November 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 pieces
Product Description
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Reason for Recall
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Distribution Pattern
Nationwide Distribution.
Code Information
Lot Numbers: LR810; LT122