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Terminated

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

FDA Recall Z-1103-2021 · Posted None

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2021-01-08
Date Terminated2024-01-17
Product Quantity60 sleeves

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063633DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVESDePuy Orthopaedics, Inc. · 2007-03-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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