Stryker Recalls Accolade Hip Stems Due to Packaging Mix-Up
Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.
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, which typically corresponds to a moderate severity score. The hazard is a packaging mix-up without reported injuries or illnesses, fitting the criteria for a moderate risk.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling specific units of the Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem. The recall involves Catalog Number 6021-2530 (Lot #40264005) and Catalog Number 6021-3535 (Lot #40163005). The intended use of these devices is for the reconstruction of the head and neck of the femoral joint.
The recall was initiated after Stryker received a report that single size 3.5 stems were packaged as size 2.5 stems. This packaging error resulted in a possible product mix. The source text notes that the lot associated with Catalog Number 6021-3535 was not received in the US.
The affected devices were distributed nationwide, including in the states of New York, New Jersey, California, and Florida. Healthcare providers and facilities should verify the catalog and lot numbers of their inventory against the recall notice to ensure they are not using the affected units.
The recalled product
- Product
- Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
Distribution
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
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
- ModerateStryker Recalls Specific Hip Stems Due to Packaging Error
FDA (Devices) · 2014-04-09
- ModerateStryker Recalls Accolade II Hip Stems Due to Packaging Error
FDA (Devices) · 2013-12-18
- ModerateHip stems recalled over potential mix of two catalog numbers in packaging
FDA (Devices) · 2025-10-08
- ModerateStryker Recalls V40 Femoral Heads Due to Assembly Issues
FDA (Devices) · 2015-03-11
- ModerateStryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors
FDA (Devices) · 2013-05-29
- HighStryker Accolade Offset Rasp Handle Recalled for Potential Fracture
FDA (Devices) · 2012-06-27