FDA Device recall Z-1918-2012
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding
- FDA Device
- Class II
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class II recall of LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding by Depuy Orthopaedics, citing dePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implan….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1918-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-16 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Reason
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
Identifiers
| code_info | Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000. |
|---|
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-1918-2012%22
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