STAGEONE recallZ-0399-2019 · Zimmer Biomet, Inc. · initiated Sep 21, 2018

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

On September 21, 2018, Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notices and Return Certification Forms to customers via courier service. Distributors are encouraged to take the following actions: Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete the Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Return Certification Form to [email protected]. c. Include a hardcopy of the Return Certification Form in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. Risk Managers are encouraged to take the following actions: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove

Recall details

Recall number

Z-0399-2019

Status

Terminated

Initiated by the company

Sep 21, 2018

Recalling firm

Zimmer Biomet, Inc.

Quantity

72 units

Product code

KWY

FDA submissions

K052990

Distribution

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

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• STAGEONE 431209

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  2 recalls0 reports
• STAGEONE 431207

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal
  2 recalls0 reports

Product lines

• STAGEONEBiomet Orthopedics, LLC · 17 models · 0 reports · 18 recalls

Other devices under the same FDA submission

2 devices cleared under K052990 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• STAGEONE 431217

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
  1 recall0 reports
• STAGEONE 431213

  Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal
  1 recall0 reports