FDA Device recall Z-1125-2016
Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL ME… 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-1125-2016 |
| 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 27 consists of all product under product code: HSB and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508 DISTAL POSTERIOR/LATERAL 234800510 DISTAL POSTERIOR/LATERAL 234800604 DISTAL POSTERIOR/LATERAL 234800606 DISTAL POSTERIOR/LATERAL 234800608 DISTAL POSTERIOR/LATERAL 234800610 DISTAL POSTERIOR/LATERAL 234800614 DISTAL POSTERIOR/LATERAL Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
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.: 61809193 61809203 61809206 61822572 61841518 61844443 61897681 61901015 62001246 62193768 62277477…lot no.: 61809193 61809203 61809206 61822572 61841518 61844443 61897681 61901015 62001246 62193768 62277477 62277478 62330721 62336479 62345698 62193768N 62277478N 62266680 61880656 62234613 62266684 62266688 62266692 62333353 61622044 62339493 62339495 62330722 61635839 62330724 61782888 61782889 61782891 61809172 61809173 61809184 61822578 61830206 61830207 61830208 61830209 61838593 61838596 61838599 61838602 61838603 61838604 61864057 61867128 61867129 61893770 61893771 61893772 61901018 61934345 61934352 61951304 61951305 61951306 61996677 62001247 62001248 62001249 62043075 62124382 62124383 62124384 62124385 62124386 62140004 62140005 62167136 62167137 62167139 62167140 62172551 62172553 62175521 62175523 62266672 62266673 62266674 62266675 62277480 62277481 62277482 62299139 62299140 62299143 62299146 62299147 62299148 62314147 62314150 62314154 62314158 62336480 62336481 62277480 |
|---|
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-1125-2016%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.