Zimmer Manufacturing Recalls Sterile Orthopedic Screws Due to Calibration Data Issues
Zimmer Manufacturing B.V. is recalling 4,335 sterile orthopedic screws and bone staples due to insufficient sealer calibration data.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source cites a data/calibration issue without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 4,335 units of sterile orthopedic implants, including Magna-FX Cann Screws, Mini Magna-FX Cann Screws, and MGII Knee Self-Tap Bone Staples. The recall covers products manufactured in the firm's Building II between August 2010 and April 2013.
The recall was initiated because of insufficient sealer calibration data for the affected sterile products. The source text does not specify the exact nature of the defect or any reported adverse health events.
The affected products were distributed nationwide in the United States. Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603500 MAGNA-FX CANN SCREW 7.0MM 114604000 MAGNA-FX CANN SCREW 7.0MM…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 4,335
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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