Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
Smith & Nephew is recalling 200 units of Journey II Uni Resection Prep Trial instruments because a manufacturing defect could cause the device to disassemble during surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (surgical instrument disassembly) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling 200 units of the Journey II Uni Resection Prep Trial, Left Medial/Right Lateral. This reusable surgical instrument is used during range of motion trialing to assess joint tension and component alignment. The affected units were distributed nationwide in the United States.
The recall was initiated because the spike rail was manufactured with an oversized thru-hole. This defect could potentially cause the dowel pin to fall out, leading to the device disassembling during use. The recall covers sizes 1 through 10, identified by specific catalog numbers and lot codes listed in the agency documentation.
Healthcare facilities and distributors should stop using the affected instruments and contact Smith & Nephew for instructions on returning the devices. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- Product
- JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional…
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 200
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 (20)
- SIZE 1
- CATALOG NUMBER: REF 74035821
- LOT/BATCH CODES: 19EM19112R
- 19FM05587R
- 19FM11174R
- 19HM18075
- 19HM19648
- 19HM21015
- 19HM21016
- 19HM23242 SIZE 2
- CATALOG NUMBER: REF 74035822
- LOT/BATCH CODES: 19EM21573R
- 19EM21573S
- 19FM05589R
- 19HM21031
- 19HM21033
- 19HM21878
- 19HM21881 SIZE 3
- CATALOG NUMBER: REF 74035823
- LOT/BATCH CODES: 19EM21578R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. 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.
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