Z-0235-2016Class II

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades...

Name: Z-0235-2016 SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades...
Creator: Stryker Sustainability Solutions
Published: 2015-10-14
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2015-10-14 / Terminated / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially... on 2015-10-14. FDA classified it as Class II and gives the reason as "It was reported that packaging was not properly sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0235-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-06
Terminated: 2016-05-06
Recalling firm: Stryker Sustainability Solutions
Product: SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
Reason for recall: It was reported that packaging was not properly sealed.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Stryker sent an Urgent Medical Device Recall letter dated October 14, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm's letter states that the use of the affected lots of the recalled product should be discontinued. Other bit and/or blade lots reprocessed by Stryker Sustainability Solutions should be considered as alternatives. A Recall Effectiveness Check Form including the quantity of affected devices shipped is enclosed. The letter states to complete the Recall Effectiveness Check Form and indicate if any devices from the affected lots remain in inventory. The form needs to be completed even if no affected product is found. Return the completed and signed form to the local Stryker Sustainability Sales Representative or email to to [email protected] If the form indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a credit for all affected devices returned. For further questions, please call (888) 888-3433.
Quantity in commerce: 1202
Distribution: US ( nationwide) Distribution to the states of : MN, OH, CA, IN, WI, FL, GA, MO, IA, MT, LA, KS, TX, TN, WY, MD, NJ, WA, PA, SC, NY, MI, AT, HI, MN, AR, AZ, IL, IA, KY, MS, UT, NC, VA, CO, ME and ID., Internationally to Canada.
Product codes and lots: Item No/Model No: 2108-109, 4125-127-090, 2108-110, 2108-115, 2108-120, 2108-151-001, 2108-152, 2108-158, 2108-182, 2108-218, 310.25, 4118-127-090, 4125-147-090, 4806-110-25, 5071-553, 6118-127-90, 6125-127-090 Lot Code: 3743743, 3750611, 3750630, 3753894, 3761982, 3775827, 3779058, 3779129, 3782549, 3782554, 3782565, 3785624, 3785630, 3785676, 3789092, 3789102, 3794000, 3794085, 3796706, 3796799, 3799827, 3802103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-06

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)