FDA Device recall Z-1981-2013
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length
- FDA Device
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length by Zimmer, citing zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facili….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1981-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-16 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Reason
Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a single packaging tray configuration, which
Identifiers
| code_info | 25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 6002803…25621400 203600 25711600 203800 25621300 25621500 203700 206500 26601000 60025547 25003900 60016485 60028037 60028040 60028041 60028042 60016492 60028045 60016487 60028036 60028038 60028039 60028043 60034329 60034330 60039203 60038245 60043146 60039161 60039170 60039173 25209700 60039184 60039186 60039201 60039207 60016491 60028044 60039214 60039217 60039218 60039220 60039222 60039223 60039224 60034328 60039158 60039199 60039216 223900 365036 365034 365037 60016497 60039221 60043147 60039166 60039168 60039182 60039183 60039209 60039219 60057784 60039213 60063014 60064868 60063150 60064885 60057785 60064862 60064867 60064886 60064888 60063042 60076067 60076073 60079812 60064887 60083643 60076089 60095965 60095967 60096024 60095966 60095988 60095986 60095978 60095989 60118708 365491 365488 365452 365495 365487 365455 365468 365460 365459 60096023 365469 365610 365470 365609 365476 3654 |
|---|
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-1981-2013%22
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