Comprehensive Shoulder System recallZ-1403-2025 · Zimmer Orthopedics Manfacturing Limited-Galway · initiated Mar 3, 2025
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Zimmer Orthopedics Manfacturing Limited-Galway or your healthcare provider. The company's action is summarized under what the company is doing.
- 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 received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On March 3, 2025, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were informed of the excess metal on the inner taper of the stem due to a chipped manufacturing tool. Customers were asked to notify all affected persons and assist their Zimmer Biomet sales representative in quarantining all affected product on hand. The products will be removed from your facility.
Recall details
- Recall number
- Z-1403-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 3, 2025
- Posted by the FDA
- Mar 20, 2025
- Recalling firm
- Zimmer Orthopedics Manfacturing Limited-Galway
- Quantity
- 90 US; 136 OUS
- Product code
- MBF
- FDA submissions
- K193038
- Distribution
- US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Product description
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Code information (models, lots, serial numbers)
Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Comprehensive® Shoulder System 113627Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall2 reports
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113605Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
- Comprehensive® Shoulder System 113606Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 recall0 reports
Product lines
Other devices under the same FDA submission
38 devices cleared under K193038 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Comprehensive® Shoulder System 118001Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED41 reports
- Hybrid Glenoid PT-113950Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED22 reports
- Comprehensive® Shoulder System 113042Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED14 reports
- Comprehensive® Shoulder System 113032Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED13 reports
- Comprehensive® Shoulder System 113632Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED5 reports
- Comprehensive® Shoulder System 113022Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- Comprehensive® Shoulder System 113044Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Shoulder System 113048Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Shoulder System 113057Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Shoulder System 113053Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Comprehensive® Shoulder System 12-113556Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED3 reports
- Comprehensive® Shoulder System 113628Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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