Zimmer Recalls CPT Hip Stems Due to Incorrect Packaging
Zimmer, Inc. is removing CPT Hip System femoral stems from the market because they were packaged in incorrect cartons and distributed internationally and domestically.
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, but the hazard is limited to incorrect packaging cartons with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is initiating a removal of the CPT Modular Stem, CPT Stem Petite, and CPT Femoral Stem 12/14 Neck Taper Extended Offset. These devices are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
The recall is being conducted because the devices were packaged in incorrect cartons and distributed both internationally and domestically. Zimmer received five complaints regarding this packaging issue.
The affected products include Item No. 00-8011-001-00, Item No. 00-8011-000-05, and Item No. 00-8114-001-10. The distribution pattern includes the United States (nationwide, including Indiana and Oklahoma) and several international countries, including Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, the UK, the Russian Federation, Slovakia, and Brazil. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 20
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)
- Lot 62017554
Distribution
Part of a larger recall action
This product is one of 3 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 3 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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZimmer Recalls CPT Hip System Components Due to Incorrect Packaging
FDA (Devices) · 2014-01-08
- ModerateZimmer Recalls CPT Femoral Stems Due to Packaging Adhesion Issue
FDA (Devices) · 2013-11-06
- ModerateZimmer Recalls Hip and Shoulder Devices Packaged in Incorrect Cartons
FDA (Devices) · 2014-01-08
- ModerateZimmer Recalls CPT Degree Taper and Femoral HD Medical Devices
FDA (Devices) · 2014-02-26
- ModerateZimmer Biomet Recalls Hip Implants Due to Packaging Residue
FDA (Devices) · 2018-03-21
- ModerateZimmer Manufacturing Recalls Sterile Hip Arthroplasty Stems Due to Calibration Issues
FDA (Devices) · 2016-03-23