UnratedMedical device recall · FDA · Published February 28, 2019
Zimmer Biomet Surgical Inserter May Not Be Sterilized Properly
Zimmer Biomet recalls sterile surgical cement plug inserters due to inadequate sterilization validation. Affected items were sold for surgical procedures. Consumers should contact the company for details.
“Zimmer Biomet Surgical Inserter May Not Be Sterilized Properly.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68930-zimmer-biomet-surgical-inserter-may-not-be-sterilized-properly. Based on FDA recall #Z-1081-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1081-2019%22&limit=1).
The FDA announced on Feb. 28, 2019, that Zimmer Biomet, Inc. voluntarily recalled its Biomet Small Diameter Cement Plug Inserter-Sterile due to a lack of adequate sterilization validation. The agency classified the Class II recall as terminated.
How to tell if you have it
Brand: Zimmer Biomet
Product: Biomet Small Diameter Cement Plug Inserter-Sterile
Item Number: 414989
Quantity: 89 units
The hazard
The recall addresses a lack of an adequate sterilization validation for the single-use accessory instrumentation. The FDA stated this defect applies to all lots of the product distributed nationwide.
Context
GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Other recent recalls of similar products include a Nov. 20, 2020 spinal rod cutter recall for fracture risk and a Sept. 24, 2020 hip cup recall for sterilant risk.
How to tell if you have this one
The product is a sterile surgical cement plug inserter with item number 414989. All lots of this item were affected.
Brand
Zimmer Biomet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Zimmer Biomet for specific instructions on how to handle the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “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 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1081-2019 (February 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1081-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.