Zimmer Manufacturing Recalls One-Piece Lag Screws Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 58,320 sterile one-piece lag 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 FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to packaging calibration data rather than a confirmed high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 58,320 units of sterile one-piece lag screws (11mm) under product code HSB. The recall affects specific lot numbers manufactured and packaged in the firm's Building II between August 2010 and April 2013. These devices are intramedullary fixation rods intended for implantation in the medullary canal of long bones for fracture fixation.
The recall was initiated due to insufficient sealer calibration data for the affected products. The source text does not report any specific illnesses, injuries, or deaths associated with this recall. The products were distributed nationwide in the United States.
Healthcare providers and consumers should stop using the affected lots and contact Zimmer Manufacturing B.V. for instructions on return or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Product 55 consists of all product under product code: HSB and same usage: Item no: 225900132 ONE-PIECE LAG SCREW 11MM 225900135 ONE-PIECE LAG SCREW 11MM 225900137 ONE-PIECE LAG SCREW 11MM 225900140 ONE-PIECE LAG SCREW 11MM 225900142 ONE-PIECE LAG SCREW 11MM 225900145…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 58,320
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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