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Health product recall

REFLECTION 3 Acetabular System-Constrained Acetabular Liner (2015-05-08)

Starting date:
May 8, 2015
Posting date:
June 3, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53657

Recalled Products

A. REFLECTION 3 Acetabular System-Constrained Acetabular Liner

Reason

Smith & Nephew has initiated a product recall of select lots of the R3 constrained acetabular liners due to a manufacturing error. The R3 constrained outer liner locking groove diameter is 0.030" oversized and may not allow the locking ring to engage into the R3 shell.

Affected products

A. REFLECTION 3 Acetabular System-Constrained Acetabular Liner

Lot or serial number
  • 14HM08141
  • 14HM08148
  • 14HM08176
Model or catalog number
  • 71339160
  • 71339162
Companies
Manufacturer
Smith & Nephew Inc.
1450 Brooks Road
Memphis, Tennessee
38116
UNITED STATES