Z-0399-2019Class II

StageOne Hip, Models 431207 & 431209Usage

Name: Z-0399-2019 StageOne Hip, Models 431207 & 431209Usage
Creator: Zimmer Biomet, Inc.
Published: 2018-09-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-09-21 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L... on 2018-09-21. FDA classified it as Class II and gives the reason as "There is a potential for comingling of the 43MM and 51 MM molds". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0399-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-21
Posted: 2018-11-07
Terminated: 2020-04-14
Recalling firm: Zimmer GmbH
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.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: There is a potential for comingling of the 43MM and 51 MM molds
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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
Quantity in commerce: 72 units
Distribution: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0399-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0399-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-07

Product code KWY

K052990Class IIStageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement StemBiomet, Inc. / cleared 2005-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)