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

FDA device recall Z-2527-2026 · posted 2026-06-23 · Open, Classified

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

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

Action taken

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 CorporateQuality.PostMarket@zimmerbiomet.com. 3. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

PHX

Quantity affected

474 units

Distribution

US Nationwide distribution.

Date initiated

2026-05-20

Date posted

2026-06-23

Location

Warsaw, IN

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