Food, drugs, devices › Smith & Nephew, Inc.
Device recall: Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral
FDA enforcement event 81100 is a device recall by Smith & Nephew, Inc. of Memphis, TN, initiated 18 Sep 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 8 May 2019. Initiation: voluntary: firm initiated. Smith & Nephew, Inc. has 107 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Smith & Nephew, Inc., Memphis, TN.
Reason for recall
"One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring."
Distribution
"US Distribution to the states of: KS and TN."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0200-2019 | Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant. | 6 units | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Smith & Nephew, Inc.
All 107 events for Smith & Nephew, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to the states of: KS and TN."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.