CLASS II Device recall · Reported 30 Nov 2016 · FDA Enforcement Report
TI Calibrated Reaming Rod, Sterile recalled by Synthes (USA) Products
Synthes (USA) Products is recalling TI Calibrated Reaming Rod, Sterile, distributed nationwide in the US. The recall was initiated on 3 Oct 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0643-2017
- FDA event ID
- 75502
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Oct 2016
- FDA classified
- 19 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Oct 2016 | Recall initiated by company | |
| 19 Nov 2016 | Classified by FDA | +47 days |
| 30 Nov 2016 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Product as listed by the FDA
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Where it was distributed
Distributed Nationwide
Questions about this recall
Why was it recalled?
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Which lots are affected?
Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049
Where was it sold?
Distributed Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 75502This product is part of a recall event; the main page for the event is Extraction Hook - Sterile for TI Cannulated Nails recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Extraction Hook - Sterile for TI Cannulated Nails recalled | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Guide Rod/ with Smooth Tip, sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Reaming Rod/, Sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Guide Rod w/Smooth Tip, Sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Reaming Rod W/Ball Tip, Sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Reaming Rod with Ball Tip & Extension/, Sterile recalled | Synthes (USA) Products | Other | Nationwide | |
| CLASS II | Reaming Rod/ w/straight Ball Tip, Sterile recalled | Synthes (USA) Products | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | 2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
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| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
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