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 26 units of the Intramedullary Bone Saw Blade Assembly model 475630 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 various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Which Products Are Affected
Intramedullary Bone Saw Blade Assembly, Model/Catalog Number: 475630, Product Description: Intramedullary Bone Saw Blade Assembly 14mm. Quantity affected: 26 units. Affected lots include: Lot 67818764 (UDI-DI (01)00887868507816(17)360221(10)67818764), Lot 67818768 (UDI-DI (01)00887868507816(17)360401(10)67818768), Lot 67954534 (UDI-DI (01)00887868507816(17)360428(10)67954534). Recall number: Z-2869-2026. Classification: Class II. Distribution pattern refers to attached consignee lists.
What You Should Do
Refer to the official FDA recall notice and attached distribution lists for identification of affected consignees and further guidance.
Why This Matters
The recall involves a medical device where compromised sterile packaging could affect product safety during use.
Source
FDA Enforcement Report, recall number Z-2869-2026, report date 20260812.
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 (1,122 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.