🔍 RecallPedia

Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162

Class I - Dangerous
🏥 Medical Devices Recalled: May 11, 2018 Smith & Nephew Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    (a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smith & Nephew, Inc.
Reason for Recall:
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Birmingham Hip Resurfacing Acetabular Cup with Impactor: (a) Size 56 mm, REF 74120156 (b) Size 64 mm, REF 74120164 (c) Size 54 mm, REF 74122154 (d) Size 58 mm, REF 74122158 (e) Size 60 mm, REF 74122160 (f) Size 62 mm, REF 74122162

Product Codes/Lot Numbers:

(a) Size 56 mm, REF 74120156, Lot 16CW01824 (b) Size 64 mm, REF 74120164, Lot 16DW10975 (c) Size 54 mm, REF 74122154, Lot 16BW17747 (d) Size 58 mm, REF 74122158, Lot 16CW16199 (e) Size 60 mm, REF 74122160, Lot 08GW18001B (f) Size 62 mm, REF 74122162, Lot 16CW20851

Distribution:

Distributed in: OH, TX, CO, TN, MI, PA, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2268-2018

Related Recalls

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Smith & Nephew

Class I - Dangerous

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

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