—#164289

Product

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

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K052792
Affected lot / code info: Lot Numbers: 17LM22019, 17LM10934, 17LM05900

Why it was recalled

Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall by letter on 05/02/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out. For further questions, please call (978) 749-1440

Recalling firm

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

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2018-05-02
Posted by FDA: 2018-05-09
Terminated: 2020-09-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.