Biomet SRS Orthopedic Implants Recall: Assembly Failure Risk
Biomet recalls specific orthopedic implants for humeral reconstruction due to assembly failure risk. The mismatched screw holes may prevent proper screw engagement during surgery in less than 1% of cases.
Lower-risk recall
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
Contact the company
What happened, in plain English
Biomet is recalling certain orthopedic implants used for humeral reconstruction because a mismatch in screw holes can cause assembly failure during surgery. If the implant has already been implanted, no action is required. Read more at govinfonow.com/recall/71852-biomet-srs-orthopedic-implants-recall-assembly-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71852-biomet-srs-orthopedic-implants-recall-assembly-failure-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1173-2018
Cite this page
“Biomet SRS Orthopedic Implants Recall: Assembly Failure Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71852-biomet-srs-orthopedic-implants-recall-assembly-failure-risk. Based on FDA recall #Z-1173-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1173-2018%22&limit=1).
Why it’s dangerous
The SRS Humeral Distal Body implant has screw holes that don't align correctly with the Discovery Elbow System Humeral Condyle. This mismatch can prevent proper screw engagement during surgery in less than 1% of cases, but does not cause injury if the implant has already been implanted.
Who’s affected
Patients who received the recalled implants for proximal humeral reconstruction are not at risk. Surgeons using the specific model numbers and lot codes listed in the recall may need to check assembly compatibility.
How to tell if you have this one
Check for model numbers 211250-211255 and lot codes listed in the recall. The recall includes specific items with UDI codes starting with 00880304850316 or 00880304850330.
- Brand
Biomet- Category
Medical device
What to do — step by step
Check Implant Status
If the implant has already been implanted, no action is required. Otherwise, contact your surgeon to verify assembly compatibility.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distribution US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 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-1173-2018 (February 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1173-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 21, 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.