Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the hazard is a mechanical failure (tab fracture) that could lead to injury, but the source text does not explicitly report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is recalling the REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, specifically the Glenosphere Helmet, 40 mm Diameter Nonsterile. The product is instrumentation used in shoulder replacement surgery, where the glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact.
The recall is being conducted because there is a potential for one or both tabs of the Trabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. The source text notes that there have been 47 reported complaints of tab fracture.
The affected units were distributed worldwide, including nationwide in the USA and internationally to numerous countries. The total quantity involved is 3,163 units across both sizes. Healthcare providers and facilities should stop using the affected instrumentation and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 3,163
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereZimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
FDA (Devices) · 2013-09-04
- HighZimmer Recalls Trabecular Metal Reverse Shoulder System Due to Disassociation
FDA (Devices) · 2014-03-05
- ModerateZimmer Recalls Reverse Glenosphere and Other Devices Due to Packaging Error
FDA (Devices) · 2014-01-08
- ModerateZimmer Biomet Recalls Reverse Shoulder Baseplates Due to Missing Adapter
FDA (Devices) · 2019-03-13
- HighZimmer Trabecular Metal Reverse Shoulder Liner Impactors Recalled for Fractures
FDA (Devices) · 2012-08-22
- HighZimmer Recalls Trabecular Metal Reverse Shoulder Liner Impactors
FDA (Devices) · 2012-08-22