Synthes 3.0 MM TI Cannulated Screw Instrument and Implant… recallZ-2265-2014 · Synthes, Inc. · initiated Jun 30, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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].
Recall details
- Recall number
- Z-2265-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 30, 2014
- Posted by the FDA
- Aug 19, 2014
- Recalling firm
- Synthes, Inc.
- Quantity
- 4
- Product code
- HWC
- FDA submissions
- K951304
- Distribution
- Distributed in the states of WI and MI.
Product description
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
2 devices cleared under K951304 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 202.636Synthes GmbH · Screw, fixation, bone1 report
- NA 202.716Synthes GmbH · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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