FDA Device recall Z-0148-2013
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato…
- FDA Device
- Class II
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class II recall of SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato… by Depuy Mitek A Johnson And Johnson, citing fracture of SPIRALOK Anchors post op, requiring patient revision.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0148-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-06 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Mitek A Johnson And Johnson |
| Distribution | US |
Product
SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Reason
Fracture of SPIRALOK Anchors post op, requiring patient revision
Identifiers
| code_info | All lot codes |
|---|
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-0148-2013%22
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