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Recall Observatory FDA recall evidence

Device 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.

Z-0399-2019

September 21, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81185
Status
Terminated
Classification
Class II
Quantity
72 units
Official record key
device-enforcement:Z-0399-2019

Official wording

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

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

Distribution pattern: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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