DePuy Universal Femoral Sleeves Recalled for Taper Dimension Issues
DePuy Orthopaedics is recalling 60 Universal Femoral Sleeves because taper dimensions may be out of specification due to a manufacturing issue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 60 Universal Femoral Sleeves. These medical devices are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
The recall was initiated because the taper dimensions of the affected sleeves may be out of specification due to a production issue during the manufacturing of these lots. The affected product numbers are 129453216, 129453226, 129453236, and 129453246, with lot numbers J85Y90, J86T23, J86T20, J8790J, and J85Y92.
The devices were distributed worldwide, including nationwide in the United States in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, and VA, as well as in Canada, China, Germany, Puerto Rico, and Switzerland. Healthcare providers should contact DePuy Orthopaedics for instructions on how to handle the recalled devices.
The recalled product
- Product
- Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 60
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 (8)
- Product No.: 129453216
- 129453226
- 129453236
- 129453246 Lot No.: J85Y90
- J86T23
- J86T20
- J8790J
- J85Y92
Distribution
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