Z-1437-2015Class II
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290
Nobel Biocare USA LLC / initiated 2015-03-09 / Terminated / root cause: manufacturing process
Nobel Biocare Usa Llc began a recall of NobelReplace CC PMC RP 4.3x8mm, Article No. 37290 on . FDA classified it as Class II and gives the reason as "A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1437-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Nobel Biocare USA LLC
- Product
- NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
- Product code
- DZE Implant, Endosseous, Root-Form
- Reason for recall
- A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Nobel Biocare sent an Important - Field Correction letter dated March 6, 2015, to all affected customers and another recall letter dated dated March 10, 2015, to all affected customers to inform them that Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of their implants. The firm's internal analysis has confirmed that this material is not according to their standards. The letters provide the problems identified and the actions to be taken. Customers were instructed to return the affected product(s) not yet used to Nobel Biocare to receive a replacement product. Customers were also instructed to complete the attached Acknowledgement form and fax it to 714-282-5073 or email it to [email protected]. Customers with questions were instructed to contact their customer service department. For questions regarding this recall call 714-282-4800.
- Quantity in commerce
- 2 units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
- Product codes and lots
- Batch No. 13011562
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1414-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1415-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1416-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1417-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1418-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1419-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1420-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1421-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1422-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1423-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1424-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1425-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1426-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1427-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1428-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1429-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1430-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1431-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1432-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1433-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1434-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1435-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1436-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1437-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1438-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1439-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1440-2015 | Class II | Terminated | Voluntary: Firm initiated |
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