Calix P PEEK Lumbar System — Class II medical device recall Z-0124-2017
Terminated recall by X Spine Systems Inc, reported 2016-10-26, distributed in AZ, CA, CO, FL, GA, ID, IN, KY…. The trials and rasps used to prepare the surgical site for placement of the implant may become detached from t
| Recall number | Z-0124-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X Spine Systems Inc, Miamisburg, OH, United States |
| Recall initiated | 2016-05-17 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2019-04-04 |
| Distributed | AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX, WV |
| Countries outside the US | AU, DE, GB, IT, MX, PT |
| Quantity | 182 units |
| Reason classes | device malfunction |
| Lot numbers | 015641-2-1, 015641-2-1R, 015641-3-1, 015641-3-1R, 015857-24-1, 015857-25-1, 020316, 020317, 020329, 020330, 020746, 020747, 19894, UP1009, UPI001, UPI002, UPI004, UPI005, UPI007, UPI008 |
| Model numbers | X034-0990, X034-0994 |
Product
Calix P PEEK Lumbar System, PLIF Rasp
Reason for recall
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
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-0124-2017. 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.