DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect
DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.
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 involves a medical device with a functional defect that prevents proper seating, creating a risk of harm during surgery. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm. The recall is due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.
The affected product is identified by Product Code 129424122, Lot Number C08294, and GTIN (01)10603295024484. The product has an expiry date of March 31, 2021. The distribution pattern indicates US distribution in the state of Tennessee.
This product is used in Knee Revision Surgery. The source text does not specify the number of units affected or report any illnesses or injuries. Healthcare providers and patients should verify their inventory and usage against the specific lot number provided.
The recalled product
- Product
- LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 1
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 (5)
- LCS COMP VVC INS SM 22.5MM
- Product Code: 129424122
- Lot# C08294
- GTIN: (01)10603295024484
- Expiry: 31-Mar-2021
Distribution
Distributed in 1 state:
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