CLASS II ONGOING Device recall · Reported 1 Jul 2026 · FDA Enforcement Report

Off-Axis Comprehensive Shoulder System, Medium, Augment recalled

Zimmer is recalling Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide, distributed nationwide in the US. The recall was initiated on 20 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467

Quantity recalled435 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2528-2026
FDA event ID: 99045
Recalling firm: Zimmer, Warsaw, IN
Classification: Class II
Status: Ongoing
Recall initiated: 20 May 2026
FDA classified: 23 Jun 2026
Reported: 1 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

20 May 2026	Recall initiated by company
23 Jun 2026	Classified by FDA	+34 days
1 Jul 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

Which lots are affected?

Lot Code: Model No. 110040241 ; UDI-DI (01)00889024681941(17)350602(10)099463 ; Lot Number 099463 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350531(10)099464 ; Lot Number 099464 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350812(10)099465 ; Lot Number 099465 Model No. 110040241 ; UDI-DI (01)00889024681941(17)350707(10)099467 ; Lot Number 099467

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 99045

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026	CLASS II	Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026	CLASS II	Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026	CLASS II	Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer	Zimmer	Foreign Material	Nationwide
1 Jul 2026	CLASS II	Off-Axis Comprehensive Shoulder System, Large, Augment recalled	Zimmer	Foreign Material	Nationwide

More recalls from Zimmer

All 539

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System, Large, Augment recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Comprehensive Shoulder System Small, Augment recalled by Zimmer	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide
1 Jul 2026Device	CLASS II	Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled	Zimmer	Packaging Defects	IN
1 Jul 2026Device	CLASS II	Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled	Zimmer	Foreign Material	Nationwide

Other Other Medical Devices recalls

All 13,857

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30 Sep 2026Device	CLASS II	Medline Convenience Kits: Major Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
30 Sep 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Mfc Craniotomy Pack recalled	Medline Industries	Other	Nationwide