Smith & Nephew recalls
22 official recalls and safety alerts involving Smith & Nephew since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Smith & Nephew or the relevant agency.
- 2026-06-24
USSmith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
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 identified before implantation, an equivalent backup can be used, or a bent…
FDA · DeviceSmith & Nephew, Inc.International distribution to the countries of BE, DE, IT.Official notice →- 2025-12-24
- US
Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
FDA · DeviceSmith & Nephew, Inc.US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN,…Official notice → - 2025-05-28
- US
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw,…
FDA · DeviceSmith & Nephew, Inc.Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH,…Official notice → - 2024-12-11
- US
Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
FDA · DeviceSmith & Nephew Inc.Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY,…Official notice → - 2024-11-13
- US
Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar…
The Bipolar assembly contains an oversized Retainer Ring.
FDA · DeviceSmith & Nephew, Inc.International distribution to the countries of Australia, Belgium, Canada,…Official notice → - 2024-11-06
- US
Smith & Nephew Inc recalls smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur…
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution…Official notice → - US
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,…
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to state of Texas and OUS (foreign) to countries of: Spain,…Official notice → - 2024-09-25
- US
Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
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 indicating that a package contained K-WIRE .062X9 2PT DM wires instead…
- 2024-09-18
- US
Smith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number:…
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
FDA · DeviceSmith & Nephew Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-06-05
- US
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA · DeviceSmith & Nephew IncInternational distribution to the countries of Australia, Germany, Japan,…Official notice → - 2023-11-01
- US
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
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 BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and…
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide and the country of Japan.Official notice → - 2023-09-27
- US
Smith & Nephew Inc recalls smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
- 2023-08-30
- US
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE…
- 2023-06-07
- US
Smith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200…
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an…
- 2023-04-26
- US
Smith & Nephew, Inc. recalls JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.Official notice → - 2022-07-27
- US
Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left,…
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 sticks.
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO,…Official notice → - 2022-05-25
- US
Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
FDA · DeviceSmith & Nephew IncWorldwide distribution - US Nationwide distribution in the states of CT, NC,…Official notice → - 2022-02-16
- US
Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic…
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, CT,…Official notice → - 2022-02-09
- US
Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CA and OH.Official notice → - 2021-12-22
- US
Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large…
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ,…Official notice → - 2021-11-24
- US
Smith & Nephew, Inc. recalls Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
The labels on the packages of screws were switched.
FDA · DeviceSmith & Nephew, Inc.Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME,…Official notice → - 2021-10-27
- US
Smith & Nephew, Inc. recalls 6.5MMX165MM CANNULATED SCREW
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide distribution in the states of OK, TN…Official notice →