Z-2461-2016Class II
DAL-RO Threaded Female Dental implants
ZimVie US Corp LLC / initiated 2015-11-25 / Terminated / root cause: packaging
Biomet 3i, LLC began a recall of DAL-RO Threaded Female Dental implants on . FDA classified it as Class II and gives the reason as "Pouches may not have been sealed during packing". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2461-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ZimVie US Corp LLC
- Product
- DAL-RO Threaded Female Dental implants
- Product code
- DZE Implant, Endosseous, Root-Form
- Reason for recall
- Pouches may not have been sealed during packing.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316. For questions regarding this recall call 561-776-6700.
- Quantity in commerce
- 1,648,273 devices (all products subject to this recall)
- Distribution
- Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
- Product codes and lots
- Item: DRAF
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2406-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2407-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2408-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2409-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2410-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2411-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2412-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2413-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2414-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2415-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2416-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2417-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2418-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2419-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2420-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2421-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2422-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2423-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2424-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2425-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2426-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2427-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2428-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2429-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2430-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2431-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2432-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2433-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2434-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2435-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2436-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2437-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2438-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2439-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2440-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2441-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2442-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2443-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2444-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2445-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2446-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2447-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2448-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2449-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2450-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2451-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2452-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2453-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2454-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2455-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2456-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2457-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2458-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2459-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2460-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2461-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2462-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2463-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2464-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2465-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2466-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2467-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2468-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2469-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2470-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2471-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2472-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2473-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2474-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2475-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2476-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2477-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2478-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2479-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2480-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2481-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2482-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2483-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2484-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2485-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2486-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2487-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2488-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2489-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2490-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2491-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2492-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2493-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2494-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2495-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2496-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2497-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2498-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2499-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2500-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2501-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2502-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2503-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2504-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2505-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2506-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2507-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2508-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2509-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2510-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2511-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2512-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2513-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2514-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2515-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2516-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2517-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2518-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2519-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2520-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2521-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2522-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2523-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2524-2016 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.