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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit

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 Class 2 Device Recall Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kitsee related information
Date Initiated by FirmAugust 24, 2020
Create DateSeptember 25, 2020
Recall Status1 Terminated 3 on May 01, 2023
Recall NumberZ-3019-2020
Recall Event ID 86396
510(K)NumberK063569 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductEquinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Code Information Catalog Number: 320-20-18  Serial Numbers: S072858, S072859, S072860, S072861, S072862, S072863, S072864, S072865, S072866, S072867, S072868, S072869, S072870, S072871, S072872, S072873, S072874, S072875, S072876, S072877, S072878, S072879, S072880, S072881, S072882, S072883, S072884, S072885, S072886, S072887, S072888, S072889, S072890, S072891, S072892, S072893, S072894, S072895, S072896, S072897, S072898, S072899, S072900, S072901, S072902, S072903, S072905,S072906, S072907, S072908, S072909, S072910, S072923, S072924, S072925, S072926, S072927, S072928, S072929, S072930, S072931, S072932, S072933, S072934, S072935, S072936, S072937, S072938, S072939, S072940, S072941, S072942, S072943, S072944, S072945, S072946, S072947, S072948, S072949, S072950, S072951, S072952, S072953, S072954, S072955, S072956, S072957, S072959, S072962, S072963, S072964, S072965, S072966, S072969, S072970, S072971, S072972, S072973, S072974, S072975, S072976, S072977, S072978, S072979, S072980, S072981, S072982, S072983, S072984, S072985, S072986, S072987, S072988, S072989, S072990, S072991, S072992, S072993, S072994, S072995, S072996, S072997, S072998, S072999.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactJean-Philippe Gobeil-Jobidon
352-377-1140
Manufacturer Reason
for Recall		Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
FDA Determined
Cause 2		Labeling Change Control
ActionOn 8/24/2020 the firm provided a letter to their consignees with the following instructions: In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of this product. " Extend this information to your accounts that may have this product in their possesrion. " Identify and quarantine any of the subject devices in your inventory (including loaer kits). " Complete and return the attached Recall Inventory Response Form to Exactech via email a recalls@exac.com.
Quantity in Commerce125 devices
DistributionDomestic Distribution: KS, CA, AR, NY, OH, IL, WI, AZ, LA, KY, VA, IN, TX, HI, MN, FL, TN, GA, ID, ME, CO, WA, SC. International Distribution: Austria, Australia, Germany, France, Spain, Italy, Japan, United Kingdom, Luxembourg, Netherlands, South Africa.
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.
510(K) Database510(K)s with Product Code = PHX
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