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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Instrument for SMR Anatomic and Reverse Shoulder Prosthesis

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 Class 2 Device Recall Surgical Instrument for SMR Anatomic and Reverse Shoulder Prosthesissee related information
Date Initiated by FirmJuly 21, 2016
Date PostedAugust 31, 2016
Recall Status1 Terminated 3 on January 13, 2017
Recall NumberZ-2707-2016
Recall Event ID 74827
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductSMR allen wrench 5 mm, product code 9013.50.210
Code Information 14AA311
FEI Number 3008021110
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
San Daniele Del Friuli Italy
For Additional Information ContactDanae Brubaker
817-3850777
Manufacturer Reason
for Recall		Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm received two complaints from the US field about the inta-operative malfunction with the SMR allen wrench 5mm (product code 9013.50.210) with the T-handle. Both parts involved were manufactured with the same lot #14AA311. No adverse effects for patients reported.
Quantity in Commerce76
DistributionUS, Italy, Australia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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