LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are… — Class I medical device recall Z-0831-2013
Terminated recall by DePuy Orthopaedics, Inc., reported 2013-02-27, distributed nationwide. DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the p
| Recall number | Z-0831-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-01-04 |
| Classified | 2013-02-15 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2014-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, NL, ZA |
| Reason classes | device malfunction |
| Lot numbers | 123510, 156211, 212355, B34GG1000, B4TH51000, B5RAX1000, B5RAXA000, B5RAXB000, CC3KX1000, CC3KXA000, E4RF31000, E4RF3A000, E55HV1, EN4KN1000 |
| Model numbers | 198720028 |
Product
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
Reason for recall
DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0831-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.