Howmedica Custom Implant System Recall: Outdated Instructions Risk Misuse
Howmedica recalls custom implant systems made between March 2007 and October 2014 due to outdated instructions that don't clarify locking mechanism function and warnings for the locking screw. Affected users should contact the company for details.
Lower-risk recall
From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
Contact the company
What happened, in plain English
Howmedica is recalling custom-made implant systems with Minimum Invasive Grower (MIG) components produced from March 2007 to October 2014. The recall is because the product did not include updated instructions that clearly explain how the locking mechanism works and warn about the locking screw. Read more at govinfonow.com/recall/72244-howmedica-custom-implant-system-recall-outdated-instructions-risk-misuse.
Source Summary by GovInfoNow · govinfonow.com/recall/72244-howmedica-custom-implant-system-recall-outdated-instructions-risk-misuse · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2567-2018
Cite this page
“Howmedica Custom Implant System Recall: Outdated Instructions Risk Misuse.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72244-howmedica-custom-implant-system-recall-outdated-instructions-risk-misuse. Based on FDA recall #Z-2567-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2567-2018%22&limit=1).
Why it’s dangerous
The product lacked updated instructions that clarify the function of the locking mechanism and warnings about the locking screw. This could lead to improper use if the user follows outdated guidance without understanding the critical safety features.
Who’s affected
Patients who received the custom implant system with MIG component between March 2007 and October 2014 are likely affected. Those who have the implant and follow the outdated instructions may face misunderstandings about the locking mechanism.
How to tell if you have this one
Check for the Prosthesis Identification Number (PIN) listed in the recall: 16082, 18313, 18666, 18713, or 18800. The implant was manufactured between March 2007 and October 2014.
- Brand
Howmedica- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Howmedica Osteonics Corp. for specific details about your implant and instructions.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “NY, FL, KS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Kansas, New York.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2567-2018 (December 21, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2567-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.