| | Class 2 Device Recall AcuMatch XLE |  |
| Date Initiated by Firm | December 31, 2024 |
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| Date Posted | February 12, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1165-2025 |
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| Recall Event ID |
96102 |
| 510(K)Number | K173583 |
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| Product Classification |
Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented - Product Code OQI
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| Product | AcuMatch XLE
Item Number / Product Description:
140-28-27 AM EHXL 0 LNR G 28MM
140-32-27 AM EHXL 0 LNR G 32MM
140-32-28 AM EHXL 0 LNR H 32MM
140-28-29 AM EHXL 0 LNR J 28MM
140-32-29 AM EHXL 0 LNR J 32MM
140-36-29 AM EHXL 0 LNR J 36MM
140-32-30 AM EHXL 0 LNR K 32MM
140-36-30 AM EHXL 0 LNR K 36MM
140-28-25 AM EHXL 0LNR E 28MM
140-28-26 AM EHXL 0LNR F 28MM
140-28-28 AM EHXL 0LNR H 28MM
140-36-28 AM EHXL 0LNR H 36MM
140-28-30 AM EHXL 0LNR K 28MM
142-28-24 AM EHXL 15 LNR D 28MM
142-28-26 AM EHXL 15 LNR F 28MM
142-32-27 AM EHXL 15 LNR G 32MM
142-32-28 AM EHXL 15 LNR H 32MM
142-36-28 AM EHXL 15 LNR H 36MM
142-36-29 AM EHXL 15 LNR J 26MM
142-28-29 AM EHXL 15 LNR J 28MM
142-32-29 AM EHXL 15 LNR J 32MM
142-28-30 AM EHXL 15 LNR K 28MM
142-32-30 AM EHXL 15 LNR K 32MM
142-36-30 AM EHXL 15 LNR K 36MM
142-28-25 AM EHXL 15LNR E 28MM
142-28-27 AM EHXL 15LNR G 28MM
142-28-28 AM EHXL 15LNR H 28MM
144-28-28 AM EHXL EXT LNR H 28MM
144-28-29 AM EHXL EXT LNR J 28MM
144-28-25 AM EHXL EXTLNR E 28MM
144-28-26 AM EHXL EXTLNR F 28MM
144-28-27 AM EHXL EXTLNR G 28MM
144-28-30 AM EHXL EXTLNR K 28MM
148-28-26 AM EHXL LAT LNR F 28MM
148-28-27 AM EHXL LAT LNR G 28MM
148-36-28 AM EHXL LAT LNR H 36MM
148-36-29 AM EHXL LAT LNR J 36MM
148-28-30 AM EHXL LAT LNR K 28MM
148-36-30 AM EHXL LAT LNR K 36MM
148-28-25 AM EHXL LATLNR E 28MM
148-28-28 AM EHXL LATLNR H 28MM
148-28-29 AM EHXL LATLNR J 28MM
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. |
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| Code Information |
Item Number / Product Description/ UDI-DI code:
140-28-27 AM EHXL 0¿ LNR G 28MM 10885862537997
140-32-27 AM EHXL 0¿ LNR G 32MM 10885862538031
140-32-28 AM EHXL 0¿ LNR H 32MM 10885862538048
140-28-29 AM EHXL 0¿ LNR J 28MM 10885862538017
140-32-29 AM EHXL 0¿ LNR J 32MM 10885862538055
140-36-29 AM EHXL 0¿ LNR J 36MM 10885862538086
140-32-30 AM EHXL 0¿ LNR K 32MM 10885862538062
140-36-30 AM EHXL 0¿ LNR K 36MM 10885862538093
140-28-25 AM EHXL 0¿LNR E 28MM 10885862537973
140-28-26 AM EHXL 0¿LNR F 28MM 10885862537980
140-28-28 AM EHXL 0¿LNR H 28MM 10885862538000
140-36-28 AM EHXL 0¿LNR H 36MM 10885862538079
140-28-30 AM EHXL 0¿LNR K 28MM 10885862538024
142-28-24 AM EHXL 15¿ LNR D 28MM 10885862538123
142-28-26 AM EHXL 15¿ LNR F 28MM 10885862538147
142-32-27 AM EHXL 15¿ LNR G 32MM 10885862538192
142-32-28 AM EHXL 15¿ LNR H 32MM 10885862538208
142-36-28 AM EHXL 15¿ LNR H 36MM 10885862538239
142-36-29 AM EHXL 15¿ LNR J 26MM 10885862538246
142-28-29 AM EHXL 15¿ LNR J 28MM 10885862538178
142-32-29 AM EHXL 15¿ LNR J 32MM 10885862538215
142-28-30 AM EHXL 15¿ LNR K 28MM 10885862538185
142-32-30 AM EHXL 15¿ LNR K 32MM 10885862538222
142-36-30 AM EHXL 15¿ LNR K 36MM 10885862538253
142-28-25 AM EHXL 15¿LNR E 28MM 10885862538130
142-28-27 AM EHXL 15¿LNR G 28MM 10885862538154
142-28-28 AM EHXL 15¿LNR H 28MM 10885862538161
144-28-28 AM EHXL EXT LNR H 28MM 10885862538291
144-28-29 AM EHXL EXT LNR J 28MM 10885862538307
144-28-25 AM EHXL EXTLNR E 28MM 10885862538260
144-28-26 AM EHXL EXTLNR F 28MM 10885862538277
144-28-27 AM EHXL EXTLNR G 28MM 10885862538284
144-28-30 AM EHXL EXTLNR K 28MM 10885862538314
148-28-26 AM EHXL LAT LNR F 28MM 10885862538338
148-28-27 AM EHXL LAT LNR G 28MM 10885862538345
148-36-28 AM EHXL LAT LNR H 36MM 10885862538383
148-36-29 AM EHXL LAT LNR J 36MM 10885862538390
148-28-30 AM EHXL LAT LNR K 28MM 10885862538376
148-36-30 AM EHXL LAT LNR K 36MM 10885862538406
148-28-25 AM EHXL LATLNR E 28MM 10885862538321
148-28-28 AM EHXL LATLNR H 28MM 10885862538352
148-28-29 AM EHXL LATLNR J 28MM 10885862538369
|
Recalling Firm/
Manufacturer |
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
|
| For Additional Information Contact | Matthew Collins
352-377-1140 |
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Manufacturer Reason
for Recall | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| Action | On 12/31/2024, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter via FedEx to customers initially informing them that the firm was recalling specific hip polyethylene liner lots that were inadvertently packaged without the ethylene vinyl alcohol (EVOH) layer in the innermost bag.
An updated customer notification letter was communicated to affected customer via email on 01/17/2025.
Customers are instructed to:
-Immediate Discontinuation: Immediately discontinue use of all affected products
-Quarantine and Return: Segregate and quarantine affected products and arrange for their return to Exactech. The Recall Confirmation Form section of this communication provides product return instructions.
Clinical Guidance:
1. Patient Monitoring: Surgeons should regularly monitor patients with affected devices for potential risks such as device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling, as per the instructions for use.
2. Diagnostic Considerations: Diagnostic imaging, such as X-rays, may be considered if device failure is suspected.
3. Revision Considerations: Revision of well-functioning devices is not recommended for patients.
4. Resources: Healthcare providers and patients with questions can access educational resources on our website exac.com/recall-information and use the device serial look-up tool.
Public Contact - 352-377-1140 or email matt.collins@exac.com |
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| Quantity in Commerce | 42 |
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| Distribution | U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA
O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = OQI
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