Product 17 consists of all product under product code: LPH and same… — Class II medical device recall Z-1115-2016
Terminated recall by Zimmer Manufacturing B.V., reported 2016-03-23, distributed nationwide. As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Aug
| Recall number | Z-1115-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Manufacturing B.V., Mercedita, PR, United States |
| Recall initiated | 2016-01-11 |
| Classified | 2016-03-12 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 87,341 |
| Reason classes | sterility |
| Lot numbers | 61573707, 61585184, 61585187, 61623552, 61623554, 61623693, 61623755, 61623804, 61623830, 61623832, 61623835, 61636597, 61636619, 61661363, 61661367, 61667818, 61667821, 61667833, 61667834, 61667843, 61667844, 61667845, 61667846, 61667850, 61667857, 61667867, 61667868, 61667869, 61667870, 61674407, 61674415, 61674417, 61674423, 61674429, 61674437, 61674438, 61674439, 61674440, 61674441, 61674442 and 460 more |
| Model numbers | 625004515 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1115-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.