Recall Z-2115-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2115-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-28, terminated 2018-07-03. It names one FDA 510(k) clearance: K933785. Product: NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.. Reason: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Terminated: 2018-07-03
Firm location: Warsaw, IN, 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 Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.

Reason for recall

Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.

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