ModerateClass IIOngoing

FDA Devices recall · Reported February 19, 2025

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 0¿LNR E 28MM 140-28-26 AM EHXL 0¿LNR F 28MM 140-28-28 AM EHXL 0¿LNR H 28MM 140-36-28 AM EHXL 0¿LNR H 36MM 140-28-30 AM EHXL 0¿LNR K 28MM 142-28-24 AM EHXL 15¿ LNR

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1165-2025.

Q: Where was the recalled product distributed?

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.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1165-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Recall #: Z-1165-2025
Affected scope: 42
Initiated: December 31, 2024

Compiled from official public sources by the editorial team. · Updated July 2026

Verify with FDA Devices →

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Exactech, Inc. recalled AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32… - a moderate-severity action.

AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32… was recalled by Exactech, Inc. in February 19, 2025. Reason: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.. Check the official notice for the remedy. Verify recall #Z-1165-2025 with the FDA Devices before acting.

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The recall

Exactech, Inc. issued this moderate-severity FDA Devices recall-Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer..

Moderate
severity level: 42 units
affected scope: Class II
classification: February 19, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1165-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1165-2025) was formally reported on February 19, 2025, with the manufacturer initiating the action on December 31, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Exactech, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 42.

The documented reason for this recall is: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

Related Recalls

3 from same agency

Product description

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 0¿LNR E 28MM 140-28-26 AM EHXL 0¿LNR F 28MM 140-28-28 AM EHXL 0¿LNR H 28MM 140-36-28 AM EHXL 0¿LNR H 36MM 140-28-30 AM EHXL 0¿LNR 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 15¿LNR E 28MM 142-28-27 AM EHXL 15¿LNR G 28MM 142-28-28 AM EHXL 15¿LNR 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.

Reason for recall

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-1165-2025
Date reported	February 19, 2025
Date initiated	December 31, 2024
Recalling firm	Exactech, Inc.
Firm location	Gainesville, FL
Affected scope	42
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

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

42 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1165-2025) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1165-2025.

Where was the recalled product distributed? ▼

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.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1165-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 19, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.