Zimmer Spine Ardis Inserter — Class I medical device recall Z-0594-2013
Terminated recall by Zimmer, Inc., reported 2013-01-02, distributed nationwide. Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lat
| Recall number | Z-0594-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-11-12 |
| Classified | 2012-12-21 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2014-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR, SG, SV |
| Quantity | 315 |
| Lot numbers | 07.00780.701, 07.00780.702, 07.00900.701, 07.00900.702, 50CL, 52ZW, 53BB, 55AB, 58GS, 58GT, 60CK, 60CL, 60JY, 60JZ, 62FH, 62KP, 63HJ, 64EY, 650-0176-01, 650-0179-01, 650-0208-01, 650-0239-01, 650-0263-01, 650-0293-01, 650-0297-01, 650-0351-01, 650-0351-02, 650-0365-01, 66PR, 68AX, 68HL, 70SG, 70SG-R, 70YT, 71JE, 72JH, 72JJ, 72LP, 73EC, 74EN and 13 more |
| Model numbers | 07.00780.701, 07.00780.702, 07.00900.701, 3256-01 |
Product
Zimmer Spine Ardis Inserter, Rx, non-sterile
Reason for recall
Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks
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-0594-2013. 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.