Z-3205-2017Class II
Thread Retrieval Drill Ref 2224
ZimVie US Corp LLC / initiated 2017-07-10 / Terminated
Zimmer Dental Inc began a recall of THREAD RETRIEVAL DRILL REF 2224 on . FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-3205-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ZimVie US Corp LLC
- Product
- Thread Retrieval Drill Ref 2224
- Product code
- DZA Drill, Dental, Intraoral
- Reason for recall
- Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
- FDA root cause
- Under Investigation by firm
- Action
- The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.
- Quantity in commerce
- 237 products
- Distribution
- US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)
- Product codes and lots
- lot # 63241114, 63321266, 63426543
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3204-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3205-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3206-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3207-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3208-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3209-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-3210-2017 | Class II | Terminated | Voluntary: Firm initiated |
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