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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 Kit see related information
Date Initiated by Firm August 24, 2020
Create Date September 25, 2020
Recall Status1 Terminated 3 on May 01, 2023
Recall Number Z-3020-2020
Recall Event ID 86396
510(K)Number K063569  
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
Product Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Code Information Catalog Number: 320-20-22 Serial Numbers: S071601, S071602, S071603, S071604, S071605, S071606, S071607, S071608, S071609, S071610, S071611, S071612, S071613, S071614, S071616, S071617, S071618, S071619, S071620, S071621, S071622, S071623, S071624, S071625, S071626, S071627, S071628, S071629, S071630, S071631, S071632, S071633, S071634, S071635, S071636, S071637, S071638, S071639, S071640, S071641, S071642, S071643, S071644, s071645, S071646, S071647, S071648, S071649, S071650, S071651, S071652, S071653, S071654, S071655, S071656, S071657, S071658, S071659, S071660, S071661, S071662, S071663, S071664, S071665, S071666, S071668, S071669, S071670, S071671, S071672, S071673, S071674, S071675, S071676, S071678, S071679, S071680, S071681, S071682, S071683, S071684, S071685, S071686, S071687, S071688, S071689, S071690, S071691, S071692, S071693, S071694, S071695, S071696, S071697, S071698, S071700, S071701, S071702, S071703, S071704, S071705, S071706, S071707, S071708, S071709, S071710, S071711, S071712, S071713, S071714, S071715, S071716, S071717, S071718, S071719, S071720, S071721, S071724, S071725, S071726, S071727, S071728, S071729, S071730, S071731, S071732, S071733, S071734, S071735, S071736, S071737, S071738, S071739, S071740, S071741, S071742, S071743, S071744, S071745, S071747, S071748, S071749, S071750, S071751, S071752, S071753, S071754, S071755, S071756, S071757, S071758, S071759, S071760, S071761, S071762, S071763, S071765, S071766, S071767, S071768, S071769, S071770, S071771, S071772, S071773, S071774, S071775, S071776, S071777, S071778, S071781, S071782, S071783, S071784, S071785, S071786, S071787, S071788, S071789, S071790, S071791, S071792, S071793, S071794, S071795, S071796, S071797, S071798, S071799, S071800.     
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Jean-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
Action On 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 Commerce 149 devices
Distribution Domestic 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 Cycle TPLC 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) Database 510(K)s with Product Code = PHX and Original Applicant = EXACTECH, INC.
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