Food, drugs, devices › Smith & Nephew Inc
Device recall: Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use in
Smith & Nephew Inc (Memphis, TN) initiated this device recall on 23 Jan 2014; FDA lists 1 product record under event 67404, classified Class II.
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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 15 Nov 2016. 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
"Inner spherical radius of the shell is undersized."
Distribution
"Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1066-2014 | Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture,… | 10 units | Class II | Terminated | 5 Mar 2014 |
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: "Inner spherical radius of the shell is undersized."
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: "Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Nov 2016. "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.