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.
FDA Recall Z-2540-2015 · Posted 2015-09-02
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Recalling FirmLimacorporate S.p.A
Recall StatusTerminated
Product CodeHSD
Date Initiated2015-08-14
Date Terminated2016-02-26
Product Quantity93 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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