Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 7, 2024
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
Zimmer, Inc. recalled CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplast… - a moderate-severity action.
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplast… was recalled by Zimmer, Inc. in August 7, 2024. Reason: Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is be…. Check the official notice for the remedy. Verify recall #Z-2450-2024 with the FDA Devices before acting.
The recall
Zimmer, Inc. issued this moderate-severity FDA Devices recall-Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is be….
- Moderate
- severity level
- Class II
- classification
- August 7, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2450-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2450-2024) was formally reported on August 7, 2024, with the manufacturer initiating the action on July 2, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 5,500 (US); 242,000 (OUS).
The documented reason for this recall is: Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution.. 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
5,500 (US); 242,000 (OUS)
Related Recalls
6
3 from same agency
Product description
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000
Reason for recall
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2450-2024 |
| Date reported | August 7, 2024 |
| Date initiated | July 2, 2024 |
| Recalling firm | Zimmer, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 5,500 (US); 242,000 (OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
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-2450-2024) 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? ▼
CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000. Recalled by Zimmer, Inc.. Units affected: 5,500 (US); 242,000 (OUS).
Why was this product recalled? ▼
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2024. Severity: Moderate. Recall number: Z-2450-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2450-2024) 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 August 7, 2024. 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.