The Recall Desk
LowFDA (Devices)·Z-0408-2018·Announced 2018-01-31

Smith & Nephew Recalls EVOS Flex Plates Due to Packaging Error

Smith & Nephew is recalling 12 units of EVOS 2.4MM Flex Plates because the packaging contained templates. The recall covers distribution to Oregon and Colombia.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a packaging-only problem (templates in packaging) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only issues.

Plain-English summary

Smith & Nephew, Inc. is recalling 12 units of EVOS 2.4MM Flex Plate 6 Hole, catalog number 72442360N. The recall is due to a packaging error where the product packaging contained templates.

The affected product is a non-sterile bone plate intended for internal fixation of small bones and small bone fragments. The recall number is Z-0408-2018. The specific lot code is 17AM14602.

The product was distributed to the state of Oregon in the United States and internationally to Colombia. Consumers and healthcare providers should stop using the affected product and contact Smith & Nephew for instructions on return or replacement.

The recalled product

Product
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and
Affected units
12

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)

  • 17AM14602

Distribution

Distributed in 1 state: