FDA Device recall Z-2539-2015
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425 by Limacorporate S P A, citing the dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2539-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-14 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Limacorporate S P A |
| Distribution | AL, CA, CO, FL, KS, LA, MI, MN, MO, MT, NC, NV, NY, OH, TX, WA |
Product
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
Reason
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Identifiers
| code_info | Lot Numbers: 14AA234, 14AA235, 14AA233 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2539-2015%22
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