—#185512

Product

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K063633
Affected lot / code info: Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

Why it was recalled

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

Timeline

Recall initiated: 2021-01-08
Terminated: 2024-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185512. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.