FDA Device recall Z-0828-2013
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t…
- FDA Device
- Class I
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class I recall of LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t… by Depuy Orthopaedics, citing 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 Sleev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0828-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-01-04 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
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
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.
Identifiers
| code_info | Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM100…Part number: 198720018 and Lot numbers: 123506, 123507, 156208, 188414, 202951, 212351, B34GC1000, B4EGN1000, B4SBM1000, B5SHY1000, DH8F91000, DH8F9A000, DH8F9B000, DH8F9C, and FE5LL1. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2013%22
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