Home / Recalls / Zimmer, Inc. / Z-1954-2013

Z-1954-2013 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-1954-2013 was initiated by Zimmer, Inc. on Jun 28, 2013 and is designated Class II. Reason for recall: There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of… The recall status is terminated (terminated Mar 2, 2015). Affected quantity: 3,163 both sizes.

Recall Details

Product Type: Devices
Report Date: Aug 21, 2013
Initiation Date: Jun 28, 2013
Termination Date: Mar 2, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,163 both sizes

Product Description

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 impaction with the glenospere impactor.

Reason for Recall

There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Korea, Lebanon, Malta, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Utd.Arab.Emir.

Code Information

60720060 60729529 60782351 60875299 60902349 60948238 60943023 60985367 61019824 61034822 61063216 61145917 61183670 61207699 61218854 61356595 61400936 61515555 61566478 61615548 61756075 61780197 61832594 61864229 61923988 61978214 62041752 62136099 62180444 62226761 and 62289420

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1954-2013
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Zimmer, Inc.

Z-2527-2026 Class II — Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2531-2026 Class II — Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog… (May 20, 2026)
Z-2529-2026 Class II — Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2528-2026 Class II — Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide… (May 20, 2026)
Z-2530-2026 Class II — Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog… (May 20, 2026)
Z-2578-2026 Class II — Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿… (May 11, 2026)
Z-1946-2026 Class II — Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and… (Mar 30, 2026)
Z-0970-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)
Z-0980-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)
Z-0972-2026 Class II — Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus… (Dec 2, 2025)