Zimmer Manufacturing Recalls Sterile Polyethylene Patches Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling sterile polyethylene patches due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.
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 illnesses, injuries, or hospitalizations. The hazard is theoretical (potential loss of sterility due to calibration data issues), fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling specific sterile polyethylene patches (product code JWH) due to insufficient sealer calibration data. The recall affects products packaged in the firm's Building II between August 2010 and April 2013.
The affected items include various sizes of polyethylene patches and specific item numbers listed under the JWH product code. The source text does not specify the exact number of units affected or the specific distribution locations, though the structured data indicates US Nationwide Distribution.
Consumers and healthcare providers should check their inventory for these specific lot numbers and product codes. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations, as the integrity of the sterile seal may be compromised.
The recalled product
- Product
- Product 59 consists of all product under product code: JWH and same usage: Item no: 42540000026 PSN ALL POLY PAT PLY 26MM 42540000029 PSN ALL POLY PAT PLY 29MM 42540000032 PSN ALL POLY PAT PLY 32MM 42540000035 PSN ALL POLY PAT PLY 35MM 42540000038 PSN ALL POLY PAT PLY 38MM
- Manufacturer
- Zimmer Manufacturing B.V.
- Category
- Medical Device — Sterile Patches
- Hazard
- Affected units
- 112,588
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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