Z-1115-2013Class II

Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) &...

Name: Z-1115-2013 Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) &...
Creator: Synvasive Technology Inc
Published: 2013-04-02
License: https://open.fda.gov/license/

Synvasive Technology, Inc. / initiated 2013-04-02 / Terminated / root cause: packaging

FDA source

Synvasive Technology Inc began a recall of Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado... on 2013-04-02. FDA classified it as Class II and gives the reason as "Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code...". 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-1115-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-02
Posted: 2013-04-15
Terminated: 2014-07-15
Recalling firm: Synvasive Technology, Inc.
Product: Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer sent a Urgent Device Removal letter dated April 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that received affected product from both Synvasive and from Zimmer Surgical will receive two customer letters, as each letter sets out specific item and lot numbers dependent upon distribution entity. Zimmer Distributors will also receive an e-mail notification. All notifications include a response form for both Synvasive and Zimmer distributors as well as customer consignees to account for product disposition (disposal in the field per facilities' sharps protocol). (1) Notifications will be mailed via Fed Ex to Risk Managers and Zimmer Distributors with inventory. (2) Notifications will be emailed to international geographies. (3) Notifications will be emailed all Zimmer Distributors. (4) A second Fed Ex mailing will be sent to domestic non-responding consignees. (5) Effectiveness phone calls will be made to any remaining domestic non-responding consignees. (6) If a customer reports they have further distributed the product, the secondary consignee identified will receive a notification from Zimmer. The scope of the recall is limited to certain confirmed lots which were shipped to the affected consignees. .E-mails, certified mail receipts, and telephone records will be the firm's course of action in monitoring effectiveness checks. All returns will be stored in a separate area away from regular inventory. Final disposition of returned product is yet to be determined. The firm's recall strategy appears to be adequate. For further questions please call (916) 939-3913.
Quantity in commerce: 3442 units per the part numbers listed
Distribution: Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.
Product codes and lots: Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1115-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1115-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)