Recall Z-2059-2017— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-12, terminated 2017-11-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Bone Dowell Harvest Tubes. Reason: mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-12
- Terminated
- 2017-11-03
- Firm location
- Warsaw, IN, United States
Product description
Bone Dowell Harvest Tubes
Reason for recall
mislabeled as 8mm tube but it is actually 9 mm in size. A 9mm subcomponent was erroneously substituted and etched as 8mm for the actual 8mm subcomponent part.
Data sourced from openFDA. This site is unofficial and independent of the FDA.