FDA Device recall Z-1115-2016
Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCRE…
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCRE… 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-1115-2016 |
| 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 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA 625004540 BONE SCREW 4.5X40 SELF-TA 625004550 BONE SCREW 4.5X50 SELF-TA 625006515 BONE SCREW 6.5X15 SELF-TA 625006520 BONE SCREW 6.5X20 SELF-TA 625006525 BONE SCREW 6.5X25 SELF-TA 625006530 BONE SCREW 6.5X30 SELF-TA 625006535 BONE SCREW 6.5X35 SELF-TA 625006540 BONE SCREW 6.5X40 SELF-TA 625006550 BONE SCREW 6.5X50 SELF-TA 625006560 BONE SCREW 6.5X60 SELF-TA 625006570 BONE SCREW 6.5X70 SELF-TA Product Usage: For use in total or hemi 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.: 61986559 61986661 62332485 62339373 62339372 61674407 61953445 62048819 62308513 62326387 62326389…lot no.: 61986559 61986661 62332485 62339373 62339372 61674407 61953445 62048819 62308513 62326387 62326389 62044206 62332484 62339371 61623552 61623554 61661363 61667818 61667821 61825066 61881292 61968207 61968208 61968209 61968210 61968212 61968213 61996180 61996181 62011506 62032192 62073694 62163394 62163395 62176480 62176481 62176482 62176484 62176485 62176490 62194287 62194288 62194295 62227248 62292597 62292598 62292599 62292600 62292601 62292602 62318725 62318726 62318818 62319085 62332482 62337854 62337855 62352228 62352230 62163394N 62319085N 61623693 61661367 61667833 61667834 61674415 61674417 61801347 61801351 61836013 61836017 61836018 61868984 61874772 61874773 61878940 61878943 61878944 61878945 61885304 61885305 61890085 61890088 61908410 61908411 61929734 61929741 61929742 61929743 61943261 61943264 61948726 61948727 61953452 61953456 61953457 61974150 61974152 61974156 |
|---|
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-1115-2016%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.