SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter
FDA device recall Z-2539-2015 · posted 2015-09-02 · Terminated
Recall details
- Recalling firm
- Limacorporate S.p.A
- Reason for recall
- The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWT
- Quantity affected
- 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.
- Date initiated
- 2015-08-14
- Date posted
- 2015-09-02
- Date terminated
- 2016-02-26
- Location
- San Daniele Del Friuli, Italy
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, (K100858) | Lima-Lto S.P.A. | 2010-12-10 |