Recall Z-2535-2016— Straumann Manufacturing, Inc.
Class II · Terminated
Class II FDA medical device recall by Straumann Manufacturing, Inc., initiated 2016-07-14, terminated 2020-11-20. It names one FDA 510(k) clearance: K150938. Product: Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512. Reason: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration.
- Recalling firm
- Straumann Manufacturing, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-07-14
- Terminated
- 2020-11-20
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
Reason for recall
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Data sourced from openFDA. This site is unofficial and independent of the FDA.