FDA Recall
Terminated
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Recall: Z-2540-2015
·
Initiated August 14, 2015
Recall
- Recall Number
- Z-2540-2015
- Event Number
- 71972
- Firm
- Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy
- FEI Number
- 3008021110
- Product Code
- HSD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 14, 2015
- Posted
- September 2, 2015
- Terminated
- February 26, 2016
Description
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; 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.
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.
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.
Quantity
93 units