The Recall Desk
ModerateFDA (Devices)·Z-1317-2014·Announced 2014-04-09

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.
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.