Recall archive
91 recalls · page 1 of 4
Reported Jun 24, 2026
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are…
FDA (openFDA device enforcement)
Reported Dec 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Removal of affected lot of screws due to labeling error.
FDA (openFDA device enforcement)
Reported May 28, 2025
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional,…
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The Bipolar assembly contains an oversized Retainer Ring.
FDA (openFDA device enforcement)
Reported Sep 25, 2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Reason for recall — Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 1, 2023
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2023
TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 26, 2023
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM…
FDA (openFDA device enforcement)
Reported Jul 27, 2022
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart…
FDA (openFDA device enforcement)
Reported Feb 16, 2022
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
FDA (openFDA device enforcement)
Reported Feb 9, 2022
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA (openFDA device enforcement)
Reported Dec 22, 2021
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details · Reason for recall — Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 24, 2021
Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand · Product · Product details — The labels on the packages of screws were switched.
FDA (openFDA device enforcement)
Reported Oct 27, 2021
6.5MMX165MM CANNULATED SCREW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
FDA (openFDA device enforcement)
Reported Jun 30, 2021
LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The device components experienced a manufacturing process error that resulted in surface damage from product handling.
FDA (openFDA device enforcement)
Reported May 5, 2021
CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
FDA (openFDA device enforcement)
Reported Feb 10, 2021
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
FDA (openFDA device enforcement)
Reported Jan 13, 2021
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Manufacturing packaging error.
FDA (openFDA device enforcement)
Reported Nov 4, 2020
5.5MM Arthrogarde Hip Access Cannula
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope…
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The anterior locking detail does not meet its design specifications.
40 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 16, 2020
EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Multiple or incorrect expiration dates were provided on the affected designation labels.
FDA (openFDA device enforcement)
Reported Aug 26, 2020
Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — The products were improperly heat treated.
FDA (openFDA device enforcement)
Reported Aug 19, 2020
Tibial knee prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smith & Nephew, Inc.
Matched: Brand — Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
1 more product in this recall
FDA (openFDA device enforcement)
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