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.
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 1/5 (Low).
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…
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- 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:
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