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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech

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  Class 2 Device Recall Exactech see related information
Date Initiated by Firm August 11, 2022
Create Date September 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1727-2022
Recall Event ID 90279
510(K)Number K041906  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product GXL acetabular liners, orthopedic hip implant component. Product Line Numbers:
a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08
b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09
c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08
d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09
e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10
Code Information a. REF 138-36-08, GUDID 10885862024787, Serial Numbers: 638430, 638433, 638451, 638462, 638467; b. REF 138-36-09, GUDID 10885862024794, Serial Numbers: 635279, 635281; c. REF 132-36-08, GUDID 10885862023353, Serial Numbers: 630606, 630607, 630609, 630610, 630611, 630612, 630613, 632796, 632797, 632799, 632800, 632801, 632802, 632803, 632805, 632806, 632807, 632808, 632809, 632810, 632812, 632813, 632814, 632815, 632817, 632818, 632819, 632822, 632823, 632824, 632826, 632829, 632830, 632832, 632834, 657859, 657861, 657862, 657863, 657865, 657866, 657867, 657868, 657869, 657870, 657871, 657873, 657875, 657876, 657877, 657878, 657880, 657882, 657883, 657885, 657886, 657887, 657888, 657890, 657891, 657892, 1116881, 1116882, 1116883, 1116886, 1116887, 1116888, 1116889, 1116890, 1116892, 1116896, 1116897, 1116899, 1116903, 1116904, 1116905; d. REF 132-36-09, GUDID 10885862023360, Serial Numbers: 638946, 638947, 638950, 643861, 643862, 643863, 643864, 643865, 643866, 643867, 643868, 643869, 643870, 643871, 643872, 643874, 643876, 643877, 643878, 643879, 643880, 643881, 643882, 643883, 643884, 645796, 645798, 645799, 645800, 645801, 645802, 645803, 645805, 645806, 645807, 828079, 828082, 828083, 828084, 828085, 828086, 828088, 828089, 828090, 828091, 828092, 1634294, 2754889; e. REF 132-36-10, GUDID 10885862023377, Serial Numbers: 632861.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
888-912-0403
Manufacturer Reason
for Recall		 Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
FDA Determined
Cause 2		 Process control
Action The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.
Quantity in Commerce 132 devices
Distribution Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = EXACTECH, INC.
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