Z-1916-2012 Class II Terminated
FDA device recall Z-1916-2012 was initiated by DePuy Orthopaedics, Inc. on May 16, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 5, 2013). Affected quantity: (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2012
- Initiation Date
- May 16, 2012
- Termination Date
- Mar 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
Product Description
LUSTER HIP SZ 2 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 for Recall
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
Distribution Pattern
Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
Code Information
Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1916-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026