Acumed Llc: Acumed Hexalob Screw Various Sizes: Ref Numbers: : 3070-27008 2.7mm X 8mm Nl Hexalobe Screw; 3070-27009 2.7mm X 9mm Nl Hexalobe Screw; 3070-27010 2...
Recall Summary Acumed LLC is recalling various sizes of Hexalob Screws (2.7mm and 3.0mm) used in wrist fixation systems because a manufacturing error can cause the screws to break during use. The recall affects patients nationwide who received these screws as part of wrist surgical procedures.
- Recalling firm
- Acumed LLC
- Product
- Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013 2.7mm x 13mm NL Hexalobe Screw; 3070-27014 2.7mm x 14mm NL Hexalobe Screw; 3070-27015 2.7mm x 15mm NL Hexalobe Screw; 3070-27016 2.7mm x 16mm NL Hexalobe Screw; 3070-27017 2.7mm x 17mm NL Hexalobe Screw; 3070-27018 2.7mm x 18mm NL Hexalobe Screw; 3076-30010 3.0mm x 10mm NL Hexalobe Screw; 3076-30012 3.0mm x 12mm NL...
- Reason
- Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-28
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/e7d1519a-2b8c-4ccb-a4ab-228dbc4c1c2a