Recall Z-1734-2022
Exactech, Inc. · initiated August 11, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665
Codes / lots: a. REF 130-28-05, GUDID 10885862021915, Serial Numbers: 693079, 693081, 693083, 693091, 793963, 793968, 793970, 793982; b. REF 130-28-06, GUDID 10885862021922, Serial Numbers: 618681, 618682, 618683, 618686, 618688, 618691, 618693, 618696, 618697, 618698, 618699, 618701, 691919, 691920, 691924, 708701, 708703, 708705, 708706, 708707, 708708, 708709, 786731, 786732, 786733, 786740, 786741, 786742, 786743, 786745, 786746, 786747, 786748, 786751, 786752, 786755, 786756, 786758, 786760, 786761, 786762, 1369855, 1369856, 1369857, 1369858, 1369861; c. REF 130-28-07, GUDID 10885862021939, Serial Numbers: 569785, 569786, 569787, 570965, 570966, 570968, 570970, 570971, 570972, 570973, 570974, 570975, 570976, 570977, 570979, 570980, 570981, 570982, 583427, 583428, 583429, 583430, 583431, 583432, 583434, 583435, 583436, 583437, 583438, 583439, 583441, 583443, 583444, 583445, 583446, 583447, 583448, 583451, 583452, 656293, 656298, 656299, 656302, 656303, 656306, 656307, 656309, 656312, 656314, 712635, 712636, 712637, 712638, 712643, 712644, 712646, 712647, 712650, 712651, 712652, 712657, 712659, 712660, 810722, 810723, 810726, 810727, 810729, 810730, 810731, 810737, 810738, 810739, 810741…
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: Process control
Action taken
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.
Details
- Recall number
- Z-1734-2022
- Initiated
- August 11, 2022
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Quantity
- 7946 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
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1725-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1726-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1727-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1728-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1729-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1730-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1731-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1732-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a.…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |
| Z-1733-2022 Class II | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL…Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the… | 08/11/2022Open, Classified |