Zimmer Herbert Bone Screws Recalled for Insufficient Sealer Calibration Data
Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws 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, but the source text does not report any illnesses or injuries. The hazard is a potential sterility issue due to insufficient calibration data, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 4,018 units of Herbert bone screws, including smooth, threaded, and cannulated models, as well as mini and Herbert/Whipple variants. The affected products are sterile and were packaged 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 product packaging. The source text does not specify any reported illnesses, injuries, or deaths associated with these devices.
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 Zimmer Manufacturing B.V. for instructions on returning or replacing the devices.
The recalled product
- Product
- Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM 47115401800 HERBERT BONE SCREW, 3.0MM 47115402000 HERBERT BONE SCREW…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 4,018
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.
See all 72 products in this recall →Related recalls
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