Z-2527-2026 Class II Ongoing
FDA device recall Z-2527-2026 was initiated by Zimmer, Inc. on May 20, 2026 and is designated Class II. Reason for recall: Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. The recall status is ongoing. Affected quantity: 474 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 474 units
Product Description
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Reason for Recall
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Distribution Pattern
US Nationwide distribution.
Code Information
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