Z-1127-2013Class II

The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5...

Name: Z-1127-2013 The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5...
Creator: Synvasive Technology Inc
Published: 2013-03-14
License: https://open.fda.gov/license/

Synvasive Technology, Inc. / initiated 2013-03-14 / Terminated / root cause: packaging

FDA source

Synvasive Technology Inc began a recall of 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... on 2013-03-14. FDA classified it as Class II and gives the reason as "Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1127-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Posted: 2013-04-17
Terminated: 2014-01-13
Recalling firm: Synvasive Technology, Inc.
Product: 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.
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.
Quantity in commerce: 100 kits
Distribution: USA Nationwide Distributor including the state of IN
Product codes and lots: Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1127-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-16

Product code HSD

K911902Class IITemperlite(tm) Saw BladeSierra Surgical, Inc. / cleared 1991-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)