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.
What this means for you
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.
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