Z-0399-2019 Class II Terminated
FDA device recall Z-0399-2019 was initiated by Zimmer Biomet, Inc. on Sep 21, 2018 and is designated Class II. Reason for recall: There is a potential for comingling of the 43MM and 51 MM molds The recall status is terminated (terminated Apr 14, 2020). Affected quantity: 72 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 14, 2018
- Initiation Date
- Sep 21, 2018
- Termination Date
- Apr 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72 units
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
Distribution Pattern
US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Code Information
Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550 Item Number 431209 Lot # 705570, UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580, UDI - (01)00880304447141(17)270916(10)705580
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0399-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026