Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2013
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, an
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
The recall
Synvasive Technology Inc issued this moderate-severity FDA Devices recall — Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade..
- Moderate
- severity level
- Class II
- classification
- April 24, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1127-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1127-2013) was formally reported on April 24, 2013, with the manufacturer initiating the action on March 14, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Synvasive Technology Inc is listed as the recalling firm, operating out of El Dorado Hills, CA. Federal records list the affected scope as 100 kits.
The documented reason for this recall is: Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. Distribution data in the federal record shows the product reached: USA Nationwide Distributor including the state of IN. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
100 kits
Related Recalls
6
6 from same agency
Product description
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Reason for recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1127-2013 |
| Date reported | April 24, 2013 |
| Date initiated | March 14, 2013 |
| Recalling firm | Synvasive Technology Inc |
| Firm location | El Dorado Hills, CA |
| Affected scope | 100 kits |
| Distribution | USA Nationwide Distributor including the state of IN |
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-1127-2013) 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? ▼
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.. Recalled by Synvasive Technology Inc. Units affected: 100 kits.
Why was this product recalled? ▼
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1127-2013.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distributor including the state of IN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1127-2013) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported April 24, 2013.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.