3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
FDA Recall Z-0442-2019 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusOpen, Classified
Product CodeHTO
Date Initiated2018-09-13
Product Quantity832
Reason for Recall
There is potential to break during use.
Firm Action
Arthrex sent letters to their consignees with the following instructions.
1. Immediately discontinue use, sale, and distribution of the affected product.
2. Please contact Arthrex Product Surveillance at 866-267-9138 or
[email protected] as soon as possible to arrange for return of the
affected product. Our Product Surveillance Specialists can provide
assistance regarding alternative solutions and are available to answer
questions regarding credit for affected devices in your possession.
3. If you are an Arthrex agency, you do not need to notify any customers as
Arthrex will be notifying customers directly.
4. If you are an Arthrex customer, you do not need to notify any patients of
this product recall.
5. If you have any questions about this product recall, please contact Arthrex
Product Surveillance at 866-267-9138 or [email protected].
Root Cause
Software change control
Distribution Pattern
Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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