FDAFDA recall Z-2527-2026 · Jul 1, 2026
Zimmer, Inc.: Off-Axis Comprehensive Shoulder System Small recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 474 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Zimmer, Inc., Warsaw, IN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-20
Source: openFDA enforcement record Z-2527-2026 · search recall number Z-2527-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.