Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 21, 2015
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lo…
Stelkast Co recalled EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is … - a moderate-severity action.
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is … was recalled by Stelkast Co in January 21, 2015. Reason: Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in …. Check the official notice for the remedy. Verify recall #Z-0970-2015 with the FDA Devices before acting.
The recall
Stelkast Co issued this moderate-severity FDA Devices recall-Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in ….
- Moderate
- severity level
- 553 units
- affected scope
- Class II
- classification
- January 21, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0970-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0970-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on December 1, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Stelkast Co is listed as the recalling firm, operating out of Mcmurray, PA. Federal records list the affected scope as 553.
The documented reason for this recall is: Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prev… Distribution data in the federal record shows the product reached: TX, MD, IN, KS, CA, PA, GA, WA, NY, IL.. 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
553
Related Recalls
6
3 from same agency
Product description
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Reason for recall
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0970-2015 |
| Date reported | January 21, 2015 |
| Date initiated | December 1, 2014 |
| Recalling firm | Stelkast Co |
| Firm location | Mcmurray, PA |
| Affected scope | 553 |
| Distribution | TX, MD, IN, KS, CA, PA, GA, WA, NY, IL. |
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-0970-2015) 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? ▼
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.. Recalled by Stelkast Co. Units affected: 553.
Why was this product recalled? ▼
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2015. Severity: Moderate. Recall number: Z-0970-2015.
Where was the recalled product distributed? ▼
Distribution: TX, MD, IN, KS, CA, PA, GA, WA, NY, IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0970-2015) 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 January 21, 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.