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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Precoat Stemmed Tibia/NexGen Nonaugmentable Tibial Component

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 Class 2 Device Recall NexGen Precoat Stemmed Tibia/NexGen Nonaugmentable Tibial Componentsee related information
Date Initiated by FirmDecember 03, 2015
Date PostedJanuary 05, 2016
Recall Status1 Terminated 3 on September 15, 2016
Recall NumberZ-0590-2016
Recall Event ID 72750
510(K)NumberK933785 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductNexGEN 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.
Code Information lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
For Additional Information ContactConsumer Relations Call Center
800-447-5633
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionZimmer 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 corporatequality.postmarket@zimmer.com. 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 quality.postmarket@zimmerbiomet.com. 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 Commerce384 distribution events; 1 unit was returned leaving 383 units .
DistributionWorldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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