DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery
DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.
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 involves a risk-of-harm medical device where the issue is a fit/looseness problem, but no injuries or illnesses are explicitly reported in the source text.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 19 units of the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740). The recall is due to two complaints reporting that the device did not fit like the trial and that the hip construct felt loose. Investigations indicated that the small size sleeve (+1.5 femoral head offset) was incorrectly used.
The affected product is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. The specific lot number is 7928614, with Catalog No. 1365-36-740 and Barcode GTIN 10603295033684.
The 19 units were distributed in the states of West Virginia, Arizona, and Alabama, as well as in Germany and Finland. The FDA has classified this recall as Class II. Healthcare providers should stop using the affected devices and contact DePuy Orthopaedics for instructions on return or replacement.
The recalled product
- Product
- Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 19
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 (1)
- Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
Distribution
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