Severity
Moderate
FDA Devices recall · Reported July 24, 2013
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm …
Synthes USA Hq, Inc. recalled Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is par… - a moderate-severity action.
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is par… was recalled by Synthes USA Hq, Inc. in July 24, 2013. Reason: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mu…. Check the official notice for the remedy. Verify recall #Z-1745-2013 with the FDA Devices before acting.
The recall
Synthes USA Hq, Inc. issued this moderate-severity FDA Devices recall-Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mu….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1745-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1745-2013) was formally reported on July 24, 2013, with the manufacturer initiating the action on May 31, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes USA Hq, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 121.
The documented reason for this recall is: Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and n… Distribution data in the federal record shows the product reached: US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.. 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
121
Related Recalls
6
3 from same agency
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1745-2013 |
| Date reported | July 24, 2013 |
| Date initiated | May 31, 2013 |
| Recalling firm | Synthes USA Hq, Inc. |
| Firm location | West Chester, PA |
| Affected scope | 121 |
| Distribution | US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY. |
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 July 24, 2013. 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.