Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup… recallZ-0027-2008 · Smith & Nephew Inc · initiated Jul 12, 2007

Why it was recalled

The carton label may not reflect the correct size of the acetabular cup.

FDA root cause category: Packaging process control

What the company is doing

The consignees were notified of the problem and the recall by initially by telephone on 07/12/2007 and followed by a letter dated 07/24/2007.

Recall details

Recall number

Z-0027-2008

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jul 12, 2007

Posted by the FDA

Oct 25, 2007

Recalling firm

Smith & Nephew Inc

Quantity

6 units

Product code

LXH

FDA submissions

P040033

Distribution

Worldwide, including USA, Australia, Belgium, Canada, Finland, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

Product description

Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component.

Other devices under the same FDA submission

57 devices cleared under P040033 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• BIRMINGHAM HIP RESURFACING (BHR) 74120156

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  3 deaths145 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120152

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  139 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74121146

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  91 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74121150

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  1 death86 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74122154

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  75 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120154

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  2 deaths70 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74122158

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  69 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120160

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  62 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120158

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  60 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120150

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  58 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74121142

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  1 death57 reports
• BIRMINGHAM HIP RESURFACING (BHR) 74120148

  Smith & Nephew, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
  1 death56 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 39402).

• Z-0016-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0017-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component.
• Z-0018-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component.
• Z-0019-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component.
• Z-0020-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component.
• Z-0021-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component.
• Z-0022-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component.
• Z-0023-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component.
• Z-0024-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component.
• Z-0025-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component.
• Z-0026-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component.
• Z-0028-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component.
• Z-0029-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0030-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component.
• Z-0031-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component.
• Z-0032-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component.
• Z-0033-2008 · Terminated
  Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component.