Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the
FDA device recall Z-2529-2018 · posted 2018-07-23 · Terminated
Recall details
- Recalling firm
- Nobel Biocare Usa Llc
- Reason for recall
- The product label has missing information, such as the lot number and expiration date, as well as other information.
- Action taken
- Nobel Biocare sent an Urgent Quality Message letter dated March 13, 2018 via email to the U.S. consignees. The letter identified the affected product, problem and actions to be taken. For question contact customer service department at 800-322-5001.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 74 units were distributed to the U.S.
- Distribution
- Worldwide Distribution - US Nationwide in AR, CA, CO, DC, FL, IL, IN, KS, MD, MI, NE, NJ, NY, ND, OH, OK, PA, SC, TX, VA, WA, WI, and WY. Foreign distribution was made to Austria, France, Germany, Hon
- Date initiated
- 2018-03-16
- Date posted
- 2018-07-23
- Date terminated
- 2018-09-11
- Location
- Yorba Linda, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOBELACTIVE MULTI UNIT ABUTMENT (K072570) | Nobel Biocare AB | 2007-12-28 |