Stryker Recalls Specific Hip Stems Due to Packaging Error
Stryker Howmedica Osteonics is recalling 48 Citation V40 Hip Stems because a left-sided implant was found in packaging labeled for a right-sided implant.
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 involves a packaging/labeling error where a left-sided implant was found in right-sided packaging. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 48 units of Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stems. The affected models include Right Size #3 (catalog # 6265-5113), Left Size #4 (catalog #6265-5104), and Right Size #4 (catalog #6265-5114). The recall was initiated after a field report indicated that a Left Size #4 hip stem was identified in packaging associated with a Right Size #3 hip stem.
The affected units were distributed nationwide in the United States. Specific lot codes for the recalled items are #43317101 (Right Size #3), #43316801 and #43316901 (Left Size #4), and #43113901 (Right Size #4). This recall is classified as Class II by the FDA.
Healthcare providers and patients should check their inventory and medical records for these specific catalog and lot numbers. If a patient has received one of these implants, they should contact their surgeon or Stryker Howmedica Osteonics for further instructions.
The recalled product
- Product
- Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 48
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 (4)
- v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101
- v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801
- lot code 43316901
- v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901
Distribution
Distributed nationwide across the United States.
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 →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- 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 Accolade Hip Stems Due to Packaging Mix-Up
FDA (Devices) · 2013-01-16
- ModerateStryker Recalls Accolade II Hip Stems Due to Packaging Error
FDA (Devices) · 2013-12-18
- ModerateStryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors
FDA (Devices) · 2013-05-29
- ModerateHip stems recalled over potential mix of two catalog numbers in packaging
FDA (Devices) · 2025-10-08
- HighExeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
FDA (Devices) · 2022-02-23
- HighExeter V40 Cemented Hip Stem Labels May Mismatch Between Sizes
FDA (Devices) · 2022-02-23