Biomet Recalls Intramedullary Bone Saw Blade Assembly
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Biomet, Inc. is recalling 11 units of the Intramedullary Bone Saw Blade Assembly (model 475640) due to potential sterile barrier packaging damage.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Zimmer Biomet is conducting a medical device recall removal for the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Which Products Are Affected
The affected product is the Intramedullary Bone Saw Blade Assembly, Model/Catalog Number: 475640, Product Description: Intramedullary Bone Saw Blade Assembly 16mm. UDI-DI (01)00887868507830(17)360316(10)67818792; Lot 67818792. A total of 11 units are affected under recall number Z-2871-2026. The recalling firm is Biomet, Inc., located at 56 E Bell Dr, Warsaw, IN 46582-6989.
What You Should Do
Refer to the attached ZFA 2026-00096_Initial Consignee List and ZFA 2026-00096_Initial Distribution History for distribution details and affected consignees. The recall was initiated voluntarily by the firm via letter.
Why This Matters
This ongoing Class II recall addresses a potential compromise to the sterile packaging of a surgical device distributed in the United States.
Source
FDA recall number Z-2871-2026, event ID 99346.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,072 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.