Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Zimmer, Inc. recalled Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241. FDA's record states the reason for recall as: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.. The recall is logged under FDA recall number Z-2528-2026 with a Class II classification.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241) and recall number Z-2528-2026, then follow Zimmer, Inc.'s recall instructions.

FDA Recall Database: Class II Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer… by Zimmer, Inc.

Zimmer, Inc. recalled Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 on 2026-07-01. FDA classified this action as a Class II recall (recall number Z-2528-2026). Reason for recall: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.. Recall status: Ongoing. This is a device-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Key facts

Recalling firm	Zimmer, Inc.
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Classification	Class II
Recall number	Z-2528-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241 -- and the recall number Z-2528-2026. If it matches, stop using or distributing it and contact Zimmer, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Zimmer, Inc. and the affected product is described in FDA's record as: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241. FDA's stated reason for the recall is: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.. The recall is tracked under FDA recall number Z-2528-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

Zimmer, Inc.’s FDA history

Argus HQ has recorded 7 total FDA actions tied to Zimmer, Inc.: 0 warning letters, 7 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Zimmer, Inc. recalled Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241. FDA's record states the reason for recall as: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.. The recall is logged under FDA recall number Z-2528-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241) and recall number Z-2528-2026, then follow Zimmer, Inc.'s recall instructions.

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Full FDA history for Zimmer, Inc.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer… by Zimmer, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-zimmer-inc-z-2528-2026

MLA

"FDA Recall Database: Class II Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer… by Zimmer, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-zimmer-inc-z-2528-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer… by Zimmer, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-zimmer-inc-z-2528-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_zimmer_inc_z_2528_2026_2026,
  title = {FDA Recall Database: Class II Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer… by Zimmer, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-zimmer-inc-z-2528-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗