Recall Z-0399-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0399-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-09-21, terminated 2020-04-14. It names one FDA 510(k) clearance: K052990. Product: StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.. Reason: There is a potential for comingling of the 43MM and 51 MM molds.

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Terminated: 2020-04-14
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K052990 — STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEMBiomet, Inc.·cleared 2005-12-16

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

StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.

Reason for recall

There is a potential for comingling of the 43MM and 51 MM molds

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