Zimmer Manufacturing Recalls 83 Sterile Bone Fixation Screws
Zimmer Manufacturing B.V. is recalling 83 sterile bone fixation screws due to insufficient sealer calibration data. The products were distributed nationwide in the US.
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 hospitalizations, injuries, or illnesses. The hazard is a potential sterility issue due to calibration data, which fits the criteria for a moderate risk without reported harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 83 units of sterile bone fixation screws, specifically product code HWC, due to insufficient sealer calibration data. The affected products were packaged in the firm's Building II between August 2010 and April 2013. These devices are intended for implantation to fix bone fractures or for bone reconstructions.
The recall covers specific item numbers including 47248001441, 47248001641, 47248001840, 47248001841, 47248002041, 47248002441, and 47248003641. The affected lots are identified by the following lot numbers: 62050736, 62230456, 62261576, 61976745, 62127763, 62230457, 62261627, 62261659, and 61955473. The products were distributed nationwide in the United States.
Healthcare providers and consumers should check their inventory for these specific lot numbers and product codes. If the affected products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 47248001841 CANC SCR 4.0MM X 18MM FUL 47248002041 CANC SCR 4.0MM X 20MM FUL…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 83
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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