SMITH & NEPHEW INC. — FDA Facility Profile
SMITH & NEPHEW INC. is an FDA-registered facility (FEI 1219602) located in MANSFIELD, MA, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 25, 2017: No Action Indicated (NAI)
- Inspections on record
- 3 (2 VAI, 1 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
- 10, latest Nov 24, 2025
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 25, 2017 | No Action Indicated (NAI) | No citations listed |
| Dec 8, 2015 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Report of risk to health (21 CFR 806.10(a)(1)) Time to report - 10 days (21 CFR 806.10(b)) |
| Aug 15, 2011 | Voluntary Action Indicated (VAI) | Design validation acceptance criteria (21 CFR 820.30(g)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 24, 2025 | Class II | Z-0957-2026 | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. Removal of affected lot of screws due to labeling error. |
| Mar 17, 2020 | Class II | Z-1756-2020 | Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
Part Number: 72202901 and 1 more product Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip… |
| Dec 30, 2019 | Class II | Z-1273-2020 | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide… Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the… |
| Dec 11, 2017 | Class II | Z-1536-2018 | Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015 Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of… |
| Mar 15, 2017 | Class II | Z-1838-2017 | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM
Product Number: 72204037
The ACUFEX… and 13 more products Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| Jul 19, 2016 | Class II | Z-2745-2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during… Sterility compromised due to breach in sterile packaging |
| Jun 15, 2016 | Class II | Z-2218-2016 | Smith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter; Part Number: 7209417, for… The device could be subject to breaches of its sterile packaging. |
| Sep 10, 2015 | Class II | Z-0155-2016 | Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile
Part Number… and 3 more products Sterility of device is compromised due to breach in the packaging |
| Jul 30, 2013 | Class II | Z-0818-2016 | High Flow Irrigation Extender; Part Number 72201021.
Arthroscopic accessories are… During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially… |
| Apr 4, 2013 | Class II | Z-0699-2016 | Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws… and 1 more product Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the… |
Facility details
- Company
- Smith & Nephew, Inc.
- Location
- MANSFIELD, MA (US)
- Source
- device