Z-2265-2014Class II

Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set

Name: Z-2265-2014 Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Creator: Synthes, Inc.
Published: 2014-06-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-06-30 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set on 2014-06-30. FDA classified it as Class II and gives the reason as "A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the...". 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-2265-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-30
Posted: 2014-08-19
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Product code: HWC Screw, Fixation, Bone
Reason for recall: A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or [email protected].
Quantity in commerce: 4
Distribution: Distributed in the states of WI and MI.
Product codes and lots: Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2265-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-18

Product code HWC

K951304Class IISynthes 2.7 Mm Cannulated Screw and Threaded WasherSynthes (Usa) / cleared 1995-06-16

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)