Product Wiki · Recalls · U.S. FDA — Device Enforcement

6.5 mm Cancellous Screw, Product code HWC, Device Listing Number… — recall Z-2153-2016

U.S. FDA — Device Enforcement · United States · 2016-02-16 · Class II

As described by U.S. FDA — Device Enforcement: 6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; ti

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2153-2016
Date of alert
2016-02-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution in the states of :AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, N/A, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Reported risk: Labeling does not match the cleared indications for use in the United States and Canada.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.