SMITH & NEPHEW, INC. — FDA Facility Profile
SMITH & NEPHEW, INC. is an FDA-registered facility (FEI 1020279) located in MEMPHIS, TN, US. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 9, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (3 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 81, latest Sep 6, 2026
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 9, 2021 | Voluntary Action Indicated (VAI) | Investigation of device failures (21 CFR 820.198(c)) |
| Feb 2, 2018 | No Action Indicated (NAI) | No citations listed |
| Aug 2, 2017 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) |
| May 11, 2017 | No Action Indicated (NAI) | No citations listed |
| Aug 17, 2016 | No Action Indicated (NAI) | No citations listed |
| Jun 27, 2014 | No Action Indicated (NAI) | No citations listed |
| Apr 23, 2009 | Voluntary Action Indicated (VAI) | Not approved or obsolete document retrieval (21 CFR 820.40(a)) Identification of actions needed (21 CFR 820.100(a)(3)) General (21 CFR 820.198(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 6, 2026 | Class II | Z-0318-2027 | EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM
REF72463106 Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM… |
| Mar 16, 2026 | Class II | Z-2456-2026 | 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… |
| Mar 18, 2025 | Class II | Z-1806-2025 | 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… |
| Oct 15, 2024 | Class II | Z-0326-2025 | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM… The Bipolar assembly contains an oversized Retainer Ring. |
| Jul 9, 2024 | Class II | Z-3171-2024 | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener and 1 more product Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was… |
| Sep 27, 2023 | Class II | Z-0157-2024 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis and 1 more product 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… |
| Jul 24, 2023 | Class II | Z-2443-2023 | TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur… and 1 more product A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant… |
| May 2, 2023 | Class II | Z-1670-2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part… and 3 more products Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint… |
| Mar 27, 2023 | Class II | Z-1393-2023 | 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… |
| Jun 27, 2022 | Class II | Z-1418-2022 | (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186.
(2) Genesis… The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and… |
Facility details
- Company
- Smith & Nephew, Inc.
- Location
- MEMPHIS, TN (US)
- Source
- device