CLASS II Device recall · Reported 27 Jun 2018 · FDA Enforcement Report
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set recalled
Synthes (USA) Products is recalling Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set, distributed in 12 states. The recall was initiated on 5 Mar 2018 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-2247-2018
- FDA event ID
- 79754
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 15 Jun 2018
- Reported
- 27 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 15 Jun 2018 | Classified by FDA | +102 days |
| 27 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Product as listed by the FDA
Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
Where it was distributed
Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
CaliforniaIllinoisIndianaKansasLouisianaMarylandNorth CarolinaNebraskaNew JerseyOregonTexasVirginia
Questions about this recall
Is Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set recalled?
Yes. Synthes (USA) Products recalled Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set on 5 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-2247-2018.
Why was it recalled?
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Which lots are affected?
H340372
Where was it sold?
Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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