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

Recall Z-2154-2016 — 7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, 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 fr

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

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2154-2016
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

Reported risk: Labeling does not match the cleared indications for use in the United States and Canada.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Related