Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill ...
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm con...
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
These examples come from this result page and are not a ranking of every recall reason.
Checking IsoTis OrthoBiologics, Inc.
Is there a recall on isotis orthobiologics, inc. right now?
This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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