Exactech recalls custom knee inserts due to vacuum packaging without an oxygen barrier layer. Affected models include 900-06-XX, 900-08-XX, 900-23-XX, and 900-30-XX series. No remedy specified in recall notice.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Exactech is recalling custom knee inserts that were packaged in vacuum bags without an additional oxygen barrier layer. This could lead to the inserts not maintaining proper sterility during surgery, potentially causing infections or complications for patients.
The vacuum bags used for packaging lacked an extra oxygen barrier layer, which could allow moisture or contaminants to enter the packaging. This might compromise the sterility of the inserts during surgery, increasing infection risks for patients.
Patients receiving custom knee inserts from Exactech's OPTETRAK system are most at risk. The recall affects specific product lines used in surgical procedures.
Check for product lines labeled as CUSTOM OPTETRAK ANGLED PS INSERT (900-06-XX), CUSTOM OPTETRAK CC TIBIAL INSERT (900-23-XX), or CUSTOM OPTETRAK CC INSERT (900-33-XX).
Look for the specific product line numbers (e.g., 900-06-XX, 900-23-XX) on the device packaging or label.
The vacuum bags used for packaging lacked an additional oxygen barrier layer, which could allow moisture or contaminants to enter the packaging and compromise sterility during surgery.
The recall notice does not specify a remedy, so Exactech has not provided instructions for returning or replacing the product.
Yes, affected models include CUSTOM OPTETRAK ANGLED PS INSERT (900-06-XX), CUSTOM OPTETRAK CC TIBIAL INSERT (900-23-XX), and CUSTOM OPTETRAK CC INSERT (900-33-XX).
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0022-2022 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0022-2022 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
