Recall Z-2216-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-2216-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-26

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-26, terminated 2018-03-30. It names one FDA 510(k) clearance: K060694. Product: Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty. Reason: Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-26
Terminated: 2018-03-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K060694 — MODULAR HYBRID GLENOIDBiomet Manufacturing Corp·cleared 2006-12-11

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

Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty

Reason for recall

Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece from the lot had scratches and the other non-confirming threads.

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