Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 20, 2013
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrume
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Synthes USA Hq, Inc. recalled Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrum… - a moderate-severity action.
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrum… was recalled by Synthes USA Hq, Inc. in November 20, 2013. Reason: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments o…. Check the official notice for the remedy. Verify recall #Z-0202-2014 with the FDA Devices before acting.
The recall
Synthes USA Hq, Inc. issued this moderate-severity FDA Devices recall-Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments o….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- November 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0202-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0202-2014) was formally reported on November 20, 2013, with the manufacturer initiating the action on October 3, 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 2979.
The documented reason for this recall is: Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. Distribution data in the federal record shows the product reached: Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.. 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
2979
Related Recalls
6
3 from same agency
Product description
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
Reason for recall
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0202-2014 |
| Date reported | November 20, 2013 |
| Date initiated | October 3, 2013 |
| Recalling firm | Synthes USA Hq, Inc. |
| Firm location | West Chester, PA |
| Affected scope | 2979 |
| Distribution | Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico. |
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-0202-2014) 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? ▼
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.. Recalled by Synthes USA Hq, Inc.. Units affected: 2979.
Why was this product recalled? ▼
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0202-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0202-2014) 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 November 20, 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.