Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 13, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anat
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to prot…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DePuy Orthopaedics, Inc. recalled Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 1… - a moderate-severity action.
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 1… was recalled by DePuy Orthopaedics, Inc. in January 13, 2021. Reason: Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex…. Check the official notice for the remedy. Verify recall #Z-0802-2021 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex….
- Moderate
- severity level
- Class II
- classification
- January 13, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0802-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0802-2021) was formally reported on January 13, 2021, with the manufacturer initiating the action on December 15, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. DePuy Orthopaedics, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 14161 lots (10 units/lot).
The documented reason for this recall is: Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-th… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution.. 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
14161 lots (10 units/lot)
Related Recalls
6
3 from same agency
Product description
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
Reason for recall
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0802-2021 |
| Date reported | January 13, 2021 |
| Date initiated | December 15, 2020 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 14161 lots (10 units/lot) |
| Distribution | Worldwide distribution - US Nationwide distribution. |
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-0802-2021) 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? ▼
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 14161 lots (10 units/lot).
Why was this product recalled? ▼
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2021. Severity: Moderate. Recall number: Z-0802-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0802-2021) 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 January 13, 2021. 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.