| Date Initiated by Firm | May 20, 2026 |
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| Date Posted | June 23, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2528-2026 |
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| Recall Event ID |
99045 |
| 510(K)Number | K241043 |
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| Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
|
| Product | Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040241 |
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| Code Information |
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
|
| FEI Number |
1000220733
|
Recalling Firm/
Manufacturer |
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact | 411 Technical Services
800-3482759 |
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Manufacturer Reason
for Recall | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | 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 |
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| Quantity in Commerce | 435 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = PHX
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