FDA Device recall Z-1914-2012
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li…
- FDA Device
- Class II
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class II recall of ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek li… 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-1914-2012 |
| 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
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43. |
|---|
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-1914-2012%22
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