Zimmer Off-Axis Shoulder System Reamer Guide Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Zimmer, Inc. is recalling 474 units of the Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide (model 110040240) due to reports of plastic guides catching and breaking.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 6, 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-devices.
What Happened
Zimmer, Inc. initiated a recall after receiving five complaints about plastic guides catching during reaming, leading to breakage.
Which Products Are Affected
The recall covers the Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number 110040240. Affected lots include Lot Number 099457 (UDI-DI (01)00889024681965(17)350601(10)099457) and Lot Number 099458 (UDI-DI (01)00889024681965(17)350712(10)099458). A total of 474 units were distributed nationwide in the United States. The recall number is Z-2527-2026.
What You Should Do
Consumers should contact Zimmer, Inc. for return or refund instructions regarding the affected devices.
Why This Matters
The breakage issue affects a surgical device used in shoulder procedures and has prompted a Class II recall across the United States.
Source
FDA recall number Z-2527-2026 (event ID 99045)
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 (916 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 6, 2026.
Frequently Asked Questions
Common questions about this FDA recall.