FDA Device recall Z-1145-2016
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR C…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR C… by Zimmer Manufacturing B V, citing as a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-11 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Manufacturing B V |
| Distribution | US |
Product
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty
Reason
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Identifiers
| code_info | lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498…lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.