FDA Device recall Z-0594-2013
Zimmer Spine Ardis Inserter, Rx, non-sterile
- FDA Device
- Class I
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class I recall of Zimmer Spine Ardis Inserter, Rx, non-sterile by Zimmer, citing 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 Interb….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0594-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-11-12 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Zimmer Spine Ardis Inserter, Rx, non-sterile
Reason
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
Identifiers
| code_info | Ardis Inserter, Part number: 3256-01, Lot: 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71…Ardis Inserter, Part number: 3256-01, Lot: 52ZW, 50CL, 53BB, 55AB, 58GS, 58GT, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, 75LE Part, 07.00780.701, lot 76CN; part 07.00780.702, lot 76CP;part 07.00900.701, lot 76TR; 07.00900.702, 76TS; 650-0297-01, 70YT; 07.00780.701, 73EC; 07.00780.702, 73EC; 07.00900.701, 76TQ; 650-0239-01, 66PR; 650-0293-01, 70SG ; 650-0293-01, 70SG-R; 650-0179-01, 60CK; 650-0176-01, 60CL; 650-0365-01, 72LP; 07.00780.701, 76CQ; 07.00780.702, 76CR; 07.00780.701, 74EN; 07.00780.702, 74EP; 650-0351-01, 72JH; 650-0351-02, 72JJ; 650-0263-01, 68HL; 650-0208-01, 62FH; 07.00900.701, 76TN; 07.00780.701, 76QG; 07.00780.701, 76LC; 07.00780.702, 76LD; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0594-2013%22
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