Smith & Nephew Recalls R3 Constrained Liner Due to Sizing Defect
Smith & Nephew is recalling 32 units of R3 Constrained Liners because the locking groove is oversized, which may prevent the locking ring from engaging properly.
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 structural defect in a medical device that may prevent proper mechanical engagement, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 32 units of the R3 Constrained Liner, Reference 71339162. The affected product is a sterile, single-use acetabular system intended for primary or revision hip replacement in patients at high risk for dislocation. The recall covers specific lot numbers: 14HM08148, 14HM08176, and 14HM08206.
The recall was initiated because the R3 Constrained outer liner locking groove diameter is 0.030 inches oversized. This defect may prevent the locking ring from engaging into the R3 shell as intended. The affected units were distributed worldwide, including in the United States (CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI) and in Australia, Switzerland, Chile, Canada, and Spain.
Healthcare providers and patients should stop using the affected R3 Constrained Liners immediately. Smith & Nephew is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 32
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 (3)
- Lot numbers: 14HM08148
- 14HM08176
- and 14HM08206
Distribution
Part of a larger recall action
This product is one of 5 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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