Severity
Moderate
FDA Devices recall · Reported September 21, 2016
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Stryker Howmedica Osteonics Corp. recalled Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provid… - a moderate-severity action.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provid… was recalled by Stryker Howmedica Osteonics Corp. in September 21, 2016. Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.. Check the official notice for the remedy. Verify recall #Z-2791-2016 with the FDA Devices before acting.
The recall
Stryker Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2791-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2791-2016) was formally reported on September 21, 2016, with the manufacturer initiating the action on June 30, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 1 unit in total.
The documented reason for this recall is: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. Distribution data in the federal record shows the product reached: US distribution to state of: CA.. 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 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.
Severity
Moderate
Affected scope
1 unit in total
Related Recalls
6
3 from same agency
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2791-2016 |
| Date reported | September 21, 2016 |
| Date initiated | June 30, 2016 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 1 unit in total |
| Distribution | US distribution to state of: CA. |
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.
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.
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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 September 21, 2016. 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.