Recall Z-0590-2016— Zimmer Manufacturing B.V.

Name: FDA recall Z-0590-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-03

Class II · Terminated

Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2015-12-03, terminated 2016-09-15. It names one FDA 510(k) clearance: K933785. 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.. Reason: 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..

Recalling firm: Zimmer Manufacturing B.V.
Classification: Class II
Status: Terminated
Initiated: 2015-12-03
Terminated: 2016-09-15
Firm location: Mercedita, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K933785 — NEXT GENERATION KNEE SYSTEMZimmer, Inc.·cleared 1995-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.