Zimmer Manufacturing Recalls Sterile Knee Arthroplasty Bone Screws
Zimmer Manufacturing B.V. is recalling 3,696 sterile MGII Knee Self-Tap Bone Screws due to insufficient sealer calibration data.
What this means for you
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 related to packaging calibration data rather than a direct, reported health threat, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 3,696 units of sterile MGII Knee Self-Tap Bone Screws used in total knee arthroplasty. The recall covers specific item numbers (511007020 through 511007045) under product code JWH. The affected products were distributed nationwide in the United States.
The recall was initiated because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The source text confirms that the affected products are sterile.
Healthcare providers and facilities should stop using the affected lots and contact Zimmer Manufacturing B.V. for instructions on return or replacement. The recall involves specific lot numbers, including 61814292, 61817008, and 61920896, among others.
The recalled product
- Product
- Product 45 consists of all product under product code: JWH and same usage: Item no: 511007020 MGII KNEE SLF-TAP BONE ST 511007025 MGII KNEE SLF-TAP BONE ST 511007030 MGII KNEE SLF-TAP BONE ST 511007035 MGII KNEE SLF-TAP BONE ST 511007040 MGII KNEE SLF-TAP BONE ST 5110070
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 3,696
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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