Biomet Intramedullary Bone Saw Blade Assembly Recall
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 12 units of the Intramedullary Bone Saw Blade Assembly (Model 475625) 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, medical-device.
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
- Product: Intramedullary Bone Saw Blade Assembly 13mm
- Model/Catalog Number: 475625
- Lot: 67818772
- UDI-DI: (01)00887868507809(17)360228(10)67818772
- Quantity: 12 units
- Recall Number: Z-2868-2026
- Classification: Class II
- Distribution: United States (refer to attached consignee lists)
What You Should Do
Affected consignees should follow instructions provided in the recall notification letter. Contact the recalling firm for return or further guidance.
Why This Matters
The Class II recall addresses a potential compromise to the sterile barrier that could affect device safety during use.
Source
FDA Enforcement Report Z-2868-2026 - Biomet, Inc., Warsaw, IN
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 (943 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.