Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 22, 2015
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Product may breach the inner and outer sterile pouches during shipping or handling.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Omnilife Science Inc. recalled Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Ap… - a moderate-severity action.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Ap… was recalled by Omnilife Science Inc. in July 22, 2015. Reason: Product may breach the inner and outer sterile pouches during shipping or handling.. Check the official notice for the remedy. Verify recall #Z-2064-2015 with the FDA Devices before acting.
The recall
Omnilife Science Inc. issued this moderate-severity FDA Devices recall-Product may breach the inner and outer sterile pouches during shipping or handling..
- Moderate
- severity level
- 146 units
- affected scope
- Class II
- classification
- July 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2064-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2064-2015) was formally reported on July 22, 2015, with the manufacturer initiating the action on June 3, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Omnilife Science Inc. is listed as the recalling firm, operating out of East Taunton, MA. Federal records list the affected scope as 146 devices.
The documented reason for this recall is: Product may breach the inner and outer sterile pouches during shipping or handling. Distribution data in the federal record shows the product reached: US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.. 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
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.
Affected scope
146 devices
Related Recalls
6
3 from same agency
Product description
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Reason for recall
Product may breach the inner and outer sterile pouches during shipping or handling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2064-2015 |
| Date reported | July 22, 2015 |
| Date initiated | June 3, 2015 |
| Recalling firm | Omnilife Science Inc. |
| Firm location | East Taunton, MA |
| Affected scope | 146 devices |
| Distribution | US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2064-2015) 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? ▼
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA). Recalled by Omnilife Science Inc.. Units affected: 146 devices.
Why was this product recalled? ▼
Product may breach the inner and outer sterile pouches during shipping or handling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 22, 2015. Severity: Moderate. Recall number: Z-2064-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2064-2015) 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 July 22, 2015. 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.