Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2018
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 i
There is a potential for comingling of the 43MM and 51 MM molds
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spa… - a moderate-severity action.
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spa… was recalled by Zimmer Biomet, Inc. in November 14, 2018. Reason: There is a potential for comingling of the 43MM and 51 MM molds. Check the official notice for the remedy. Verify recall #Z-0399-2019 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-There is a potential for comingling of the 43MM and 51 MM molds.
- Moderate
- severity level
- 72 units
- affected scope
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0399-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0399-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on September 21, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 72 units.
The documented reason for this recall is: There is a potential for comingling of the 43MM and 51 MM molds Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
72 units
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0399-2019 |
| Date reported | November 14, 2018 |
| Date initiated | September 21, 2018 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 72 units |
| Distribution | US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0399-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 72 units.
Why was this product recalled? ▼
There is a potential for comingling of the 43MM and 51 MM molds
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0399-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: AZ, FL, MI, OH, VA & WI.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0399-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.