The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2158-2016·Announced 2016-07-20

Synthes Recalls 3.5 mm and 4.0 mm Cannulated Screws for Labeling Errors

Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws because the labeling does not match the cleared indications for use in the United States and Canada.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the indications for use do not match the cleared indications. No injuries, illnesses, or deaths are reported in the source text, and the hazard is administrative rather than a direct physical defect causing harm.

Plain-English summary

Synthes (USA) Products LLC is recalling 3.5 mm and 4.0 mm Cannulated Screws, Product code HWC, Device Listing Number D029094. The recall involves 19,497,844 units distributed nationwide across all 50 states, the District of Columbia, and Puerto Rico.

The recall was initiated because the product labeling does not match the cleared indications for use in the United States and Canada. The devices are intended for fracture fixation of large bones and large bone fragments, including femoral neck fractures and slipped capital femoral epiphyses.

Healthcare providers and facilities should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions on the recall process.

The recalled product

Product
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, 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…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
19,497,844

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Many affected part numbers

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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