Zimmer Manufacturing Recalls Sterile Orthopedic Fixation Devices Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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. The hazard involves insufficient sealer calibration data, which is a quality control issue that may compromise sterility, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific sterile orthopedic fixation devices, including the 4.5 Broad SCP Plate with 26 Holes (Item No. 47494502601). These temporary internal fixation devices are designed to stabilize fractures during the normal healing process.
The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile. The specific lot number identified in the recall is 61889853.
The recall covers US Nationwide Distribution. Consumers and healthcare providers should check their inventory for the affected item numbers and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or distributor for further instructions.
The recalled product
- Product
- Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
- Manufacturer
- Zimmer Manufacturing B.V.
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 (1)
- lot no: 61889853
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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