CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report
Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile recalled
Synthes (USA) Products is recalling Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile, Rapid Resorbable Fixation System, distributed nationwide in the US. The recall was initiated on 2 May 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-1919-2016
- FDA event ID
- 74053
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2016
- FDA classified
- 7 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 2 May 2016 | Recall initiated by company | |
| 7 Jun 2016 | Classified by FDA | +36 days |
| 15 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Product as listed by the FDA
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Where it was distributed
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
Nationwide AlabamaCaliforniaColoradoDelawareIllinoisKansasMichiganMissouriNorth CarolinaNew JerseyOklahomaPennsylvaniaSouth CarolinaTexasUtahWisconsin
Questions about this recall
Why was it recalled?
Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
Which lots are affected?
Catalog # 851.690.01S, Lot # 6904416, 6904418, 7672126
Where was it sold?
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
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
2 other products · FDA event 74053| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile recalled | Synthes (USA) Products | Labeling Errors | Nationwide | |
| CLASS II | Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile recalled | Synthes (USA) Products | Labeling Errors | Nationwide |
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