Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 20, 2022
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Waldemar Link GmbH & Co. Kg (Mfg Site) recalled Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-… - a moderate-severity action.
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-… was recalled by Waldemar Link GmbH & Co. Kg (Mfg Site) in July 20, 2022. Reason: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This m…. Check the official notice for the remedy. Verify recall #Z-1377-2022 with the FDA Devices before acting.
The recall
Waldemar Link GmbH & Co. Kg (Mfg Site) issued this moderate-severity FDA Devices recall-There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This m….
- Moderate
- severity level
- 4K units
- affected scope
- Class II
- classification
- July 20, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1377-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1377-2022) was formally reported on July 20, 2022, with the manufacturer initiating the action on May 24, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Waldemar Link GmbH & Co. Kg (Mfg Site) is listed as the recalling firm, operating out of Norderstedt. Federal records list the affected scope as 3785.
The documented reason for this recall is: There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. Distribution data in the federal record shows the product reached: Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia…. 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
3785
Related Recalls
6
3 from same agency
Product description
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Reason for recall
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1377-2022 |
| Date reported | July 20, 2022 |
| Date initiated | May 24, 2022 |
| Recalling firm | Waldemar Link GmbH & Co. Kg (Mfg Site) |
| Firm location | Norderstedt |
| Affected scope | 3785 |
| Distribution | Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France G… |
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-1377-2022) 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? ▼
Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.. Recalled by Waldemar Link GmbH & Co. Kg (Mfg Site). Units affected: 3785.
Why was this product recalled? ▼
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1377-2022.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1377-2022) 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 20, 2022. 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.