CLASS II Device recall · Reported 24 Feb 2016 · FDA Enforcement Report
Legion(tm) Hemi Stepped, Tibial Screw-on Wedge recalled
Smith & Nephew is recalling Legion(tm) Hemi Stepped, Tibial Screw-on Wedge, distributed in Kansas, Ohio, Tennessee, Wisconsin. The recall was initiated on 18 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0816-2016
- FDA event ID
- 73164
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jan 2016
- FDA classified
- 17 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 18 Jan 2016 | Recall initiated by company | |
| 17 Feb 2016 | Classified by FDA | +30 days |
| 24 Feb 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
Where it was distributed
Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
Questions about this recall
Why was it recalled?
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
Which lots are affected?
14KM16422
Where was it sold?
Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Smith & Nephew
All 258| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew | Smith & Nephew | Other | DE |
| Device | CLASS II | Biosure HA Screw Threaded metallic bone fixation fastener recalled | Smith & Nephew | Labeling Errors | Nationwide |
| Device | CLASS II | Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew | Smith & Nephew | Other | Nationwide |
| Device | CLASS II | Bioraptor Suture Anchors recalled by Smith & Nephew | Smith & Nephew | Sterility | Nationwide |
| Device | CLASS II | Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew | Smith & Nephew | Other | TN |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |