Zimmer Manufacturing B.V.: Medical Device Recall in 2016 - (Recall #: Z-0590-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 3, 2015

Date Posted: January 13, 2016

Recall Number: Z-0590-2016

Event ID: 72750

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.

Status: Terminated

Product Quantity: 384 distribution events; 1 unit was returned leaving 383 units .

Code Information:

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

Distribution Pattern:

Worldwide Distribution to Germany, Belgium, Denmark, France, UK, Greece, Ireland, Netherlands, Norway, Russian Fed., Saudi Arabia, Sweden, and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated