The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2156-2016·Announced 2016-07-20

Synthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch

Synthes (USA) Products LLC is recalling 4.5 mm Cortex 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 text does not match cleared indications. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as Moderate.

Plain-English summary

Synthes (USA) Products LLC is recalling 4.5 mm Cortex Screws (Product code HWC, Device Listing Number D137402). The recall involves 19,497,844 units distributed nationwide across the United States.

The recall was initiated because the product labeling does not match the cleared indications for use in the United States and Canada. The device is intended for fracture fixation of large bones and large bone fragments, including femoral neck fractures and tibial plateau fractures.

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

The recalled product

Product
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, 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…
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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