Recall Z-2539-2015 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Limacorporate S.p.A
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.
| Date | Sep 2, 2015 (initiated Aug 14, 2015) |
| Status | Terminated |
| Reason | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. |
| Root cause | Nonconforming Material/Component |
| Action | Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form. |
| Quantity | 110 units |
| Distribution | US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, Lima-Lto S.P.A., Dec 10, 2010 |