Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device with a potential sterility breach (sealer calibration issue), which poses a risk of harm (infection) even though no specific injuries are reported in the text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods, Item no. 522007300, used in total knee arthroplasty. The affected products are identified by product code JWH and lot number 62207450. These items 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 notes that the affected products are sterile, implying a potential risk to sterility integrity due to the calibration issue.
Healthcare providers and patients should stop using the affected lots and contact Zimmer Manufacturing B.V. for further instructions or replacement.
The recalled product
- Product
- Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- lot no.: 62207450
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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