Z-0590-2016Class II
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable...
Zimmer Manufacturing B.V. / initiated 2015-12-03 / Terminated / root cause: labeling and UDI
Zimmer Manufacturing B.V. began a recall of NexGEN System REF Tibial Component Size Stemmed 3 Precoat, and REF Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3... on . FDA classified it as Class II and gives the reason as "A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0590-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer Manufacturing B.V.
- Product
- NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis.
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling mix-ups
- Action
- Zimmer Biomet sent an "Urgent Medical Device Recall-Lot Specific" letter to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to do the following: Review the notification and ensure affected personnel are aware of the contents. 2. Locate all affected product identified above and quarantine them immediately. 3. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1). Email a completed copy of Attachment 1 to [email protected]. 4. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1). Clearly mark the outside carton of each product return shipment made as Recall. 5. Please notify Zimmer Biomet of any hospitals to which you have further distributed the affected product. Supply the information for any hospitals that you have identified, as well as the affected surgeons, using the provided spreadsheet template. The template will be emailed to you for completion. Please return to corporate [email protected]. 6. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
- Quantity in commerce
- 384 distribution events; 1 unit was returned leaving 383 units .
- Distribution
- Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
- Product codes and lots
- lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0590-2016 | 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.