The Recall Desk
HighFDA (Devices)·Z-1921-2018·Announced 2018-05-30

Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device (undersized taper) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smith & Nephew, Inc. is recalling 13 units of the Anthology HO Porous size 7 hip prosthesis stems. The recall involves three specific lots: 17LM22019, 17LM10934, and 17LM05900. These devices were distributed nationwide in the United States.

The recall was initiated because the device taper length was incorrectly manufactured. The stems were produced with a taper length of 0.393mm instead of the correct 0.442mm. This manufacturing error affects the structural integrity of the hip prosthesis component.

Healthcare providers and patients who have received these specific hip prosthesis stems should contact Smith & Nephew for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot Numbers: 17LM22019
  • 17LM10934
  • 17LM05900

Distribution

Distributed nationwide across the United States.