Z-2540-2015 Class II Terminated
FDA device recall Z-2540-2015 was initiated by Limacorporate S.p.A on August 14, 2015 and is designated Class II. 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. The recall status is terminated (terminated February 26, 2016). Affected quantity: 93 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- August 14, 2015
- Termination Date
- February 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93 units
Product 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 for Recall
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Distribution Pattern
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.
Code Information
Lot Numbers: 14AA146 and 14AA153