Z-1792-2021Class II
Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended...
Zimmer GmbH / initiated 2021-05-07 / Terminated / root cause: manufacturing process
Zimmer GmbH began a recall of Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization... on . FDA classified it as Class II and gives the reason as "Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1792-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
- Product code
- HSB Rod, Fixation, Intramedullary And Accessories
- Reason for recall
- Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
- Root cause tag
- manufacturing process
- FDA root cause
- Process design
- Action
- Zimmer Biomet Zimmer Biomet notifed distributors with direct sales and/or fielded inventory via email and traceable letter sent via FedEx. Hospitals with direct sales or current inventory notified via on 5/11/21. Letter states reason for recall, health risk and action to take: Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form for each return and send to [email protected]. This form must be returned even if you do not have affected products available to return in your territory. b. For International Returns, request an IRA by emailing [email protected] c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00p
- Quantity in commerce
- 8 units
- Distribution
- CA, GA, KY, MD Foreign: Australia Brazil, Canada Netherlands
- Product codes and lots
- Lot Number: 3020731 UDI: (01) 0088902498880 (17) 300131 (10) 3020731
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1792-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1793-2021 | Class II | Terminated | Voluntary: Firm initiated |
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