Zimmer Biomet Recalls Oxford Fixed Lateral Bearings Due to Mislabeling
Zimmer Biomet is removing a specific lot of Oxford Fixed Lateral Bearings because packages labeled as 'Right' contained 'Left' bearings.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a significant medical error (wrong side implant) which poses a risk of harm, but the source does not report injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to a mislabeling issue. The company received product complaints indicating that when a package labeled as a 'Right' bearing was opened, it actually contained a 'Left' bearing.
The affected product is the Oxford Fixed Lateral Bearing Size F Right, Part Number 154375, Lot 744260. The source text notes that 12 units were distributed. The distribution pattern indicates no domestic distribution, with units sent to the Netherlands and Switzerland. No distribution to VA/DOD facilities is reported.
This recall is classified as Class II by the FDA. The hazard involves the potential implantation of the wrong side of the knee joint component, which is a significant medical error but does not involve a structural defect or reported injury in the source text.
The recalled product
- Product
- Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed.…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
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 (3)
- Oxford Fixed Lateral Bearing Size F Right
- Part Number 154375 Lot 744260
- Date of Mfg. 26 Apr 2015
Distribution
Distribution scope not specified by the agency.
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