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NexGEN System REF 5980-37-01 Tibial Component Size Stemmed… recallZ-0590-2016 · Zimmer Manufacturing B.V. · initiated Dec 3, 2015

Class II Terminated All recalls posted in January 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Manufacturing B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0590-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 3, 2015
Posted by the FDA
Jan 5, 2016
Recalling firm
Zimmer Manufacturing B.V.
Quantity
384 distribution events; 1 unit was returned leaving 383 units .
Product code
JWH
FDA submissions
K933785
Distribution
Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.

Product description

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.

Code information (models, lots, serial numbers)

lots 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)

Other devices under the same FDA submission

89 devices cleared under K933785 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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