Smith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
Smith & Nephew is recalling 195 reusable surgical instruments because a manufacturing defect could cause the device to disassemble during use.
What this means for you
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 surgical instrument that could disassemble during a procedure, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 195 units of the JOURNEY II Uni Resection Prep Trial, Right Medial/Left Lateral. These are reusable surgical instruments used during range of motion trialing to assess joint tension and component alignment during surgery. The affected units were distributed nationwide in the United States.
The recall was initiated because the spike rail on the device 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 specific catalog numbers and lot codes for sizes 1 through 10.
Healthcare providers and facilities that have received these instruments should stop using them immediately. Smith & Nephew is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT 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 moveable
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 195
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 74035831
- LOT/BATCH CODES: 19FM01064R
- 19HM18082
- 19HM21871
- 19JM18534
- 19JM21086
- 19KM07281
- 19KM15577 SIZE 2
- CATALOG NUMBER: REF 74035832
- LOT/BATCH CODES: 19EM21587R
- 19FM11181R
- 19HM21899
- 19HM21902
- 19HM21903
- 19JM21089 SIZE 3
- CATALOG NUMBER: REF 74035833
- LOT/BATCH CODES: 19GM21768
- 19HM18085
- 19HM18085A
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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