Biomet Central Screw 25mm Recall: Wrong Length Risk
Biomet recalls 25mm shoulder screws labeled as 25mm but packaged as 40mm. This mismatch could cause improper implant fixation. Affected units include model 115395 with lot 077170.
Lower-risk recall
Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
Contact the company
What happened, in plain English
Biomet is recalling shoulder screws that were mistakenly labeled as 25mm but packaged as 4:00mm. Using the wrong size could lead to improper implant fixation and potential complications after surgery. Read more at govinfonow.com/recall/63414-biomet-central-screw-25mm-recall-wrong-length-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63414-biomet-central-screw-25mm-recall-wrong-length-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1131-2021
Cite this page
“Biomet Central Screw 25mm Recall: Wrong Length Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63414-biomet-central-screw-25mm-recall-wrong-length-risk. Based on FDA recall #Z-1131-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2021%22&limit=1).
Why it’s dangerous
The screws were packaged as 25mm but labeled as 40mm. Using a longer screw than intended could cause improper implant fixation, potentially leading to complications after surgery.
Who’s affected
Orthopedic surgeons and patients who received the Central Screw 6.5x25mm (model 115395) for shoulder replacements are affected. Those who have the screws from lot 077170 are most at risk.
How to tell if you have this one
Check for model number 115395 and lot number 077170 on the packaging. The screws are used for shoulder prostheses and are sterile.
- Brand
Biomet- Product
Central Screw 6.5x25mm- Category
Medical device
What to do — step by step
Check Product Label
Look for model number 115395 and lot number 077170 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
FDA distribution: “US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Kentucky, Michigan, Minnesota, Mississippi, Ohio, Tennessee, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 2.1 years 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-1131-2021 (January 15, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1131-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.