Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files
Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. These digital templates are used for preoperative planning of orthopedic surgery. The recall was initiated because the digital templates were created with the incorrect files.
The recall involves 3,232 units. The products were distributed worldwide, including the United States (nationwide including Puerto Rico), Canada, and numerous other countries such as Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Consumers and healthcare providers should stop using the affected digital templates and contact Zimmer Biomet, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
- Manufacturer
- Zimmer Biomet, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 3,232
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Orthosize Templating Version 1.2.6
Distribution
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateZimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle
FDA (Devices) · 2018-08-22
- ModerateZimmer Manufacturing Recalls Hip Stems Due to Insufficient Sealer Calibration Data
FDA (Devices) · 2016-03-23
- ModerateZimmer Recalls CPT Modular Hip Stems Due to Packaging Errors
FDA (Devices) · 2012-10-24
- ModerateZimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems
FDA (Devices) · 2018-08-22
- ModerateZimmer Recalls CPT Hip Stems Due to Incorrect Packaging
FDA (Devices) · 2012-10-24
- ModerateZimmer Recalls CPT Hip Stems Due to Incorrect Packaging Cartons
FDA (Devices) · 2012-10-24