Recall Z-0591-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0591-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-10-10, terminated 2020-04-28. It names one FDA 510(k) clearance: K060692. Product: Comprehensive Mini Stem, Item No. 113631:. Reason: Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-10
Terminated: 2020-04-28
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060692 — COMPREHENSIVE PRIMARY SHOULDER STEMSBiomet Manufacturing Corp·cleared 2006-05-30

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

Comprehensive Mini Stem, Item No. 113631:

Reason for recall

Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

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