Recall Z-1024-2017— Zimmer Biomet, Inc.

Name: FDA recall Z-1024-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-12-19, terminated 2017-09-19. It names one FDA 510(k) clearance: K110555. Product: RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223. Reason: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Terminated: 2017-09-19
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K110555 — ARCOMXL ACTIVE ARTICULATIONBiomet Manufacturing Corp·cleared 2011-03-24

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

RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

Reason for recall

Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

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