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Comprehensive recallZ-2527-2026 · Zimmer, Inc. · initiated May 20, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE RECALL CORRECTION notification letter dated 5/26/26 was sent to customers. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement for each return and send to [email protected]. 3. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons who are current users of the affected products that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-348-2759 between 8:00 a.m. and 5:00 p.m. Eastern, Monday through Friday. Alternatively, your questions may be emailed to [email protected]. Risk Manager Responsibilities: 1. Review this correction notice and ensure that affected personnel are aware of the contents. 2. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 3. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 4. If you have further questions or concerns after reviewing this notice, please call customer service at 1-800-348-2759 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, y

Recall details

Recall number
Z-2527-2026
Status
Open, Classified
Initiated by the company
May 20, 2026
Posted by the FDA
Jun 23, 2026
Recalling firm
Zimmer, Inc.
Quantity
474 units
Product code
PHX
FDA submissions
K241043
Distribution
US Nationwide distribution.

Product description

Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

Code information (models, lots, serial numbers)

Lot Code: Model No. 110040240 ; UDI-DI (01)00889024681965(17)350601(10)099457 ; Lot Number 099457 Model No. 110040240 ; UDI-DI (01)00889024681965(17)350712(10)099458 ; Lot Number 099458

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K241043 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 99045).

Sources and updates

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