GXL acetabular liners recall
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.…
Why was GXL acetabular liners recalled?
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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.…
- Recalling firm
- Exactech, Inc.
- Quantity
- 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
- Recall date
- September 21, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)