Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM
FDA device recall Z-2746-2015 · posted 2015-09-10 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NXT
- Quantity affected
- 10,167 units
- Distribution
- Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, N
- Date initiated
- 2015-06-03
- Date posted
- 2015-09-10
- Date terminated
- 2017-01-21
- Location
- Memphis, TN
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