—#139520

Product

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

FDA product code: NXT — Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P040033
Affected lot / code info: all codes

Why it was recalled

The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

Root cause (FDA determination)

Device Design

Action the firm took

Smith & Nephew sent an notification letter dated June 3, 2015 to customers via E-mail and Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).

Timeline

Recall initiated: 2015-06-03
Posted by FDA: 2015-09-10
Terminated: 2017-01-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.