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-1920-2016
- 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 / 35 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
Is Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile, Rapid Resorbable Fixation System recalled?
Yes. Synthes (USA) Products recalled Rapid Resorb Orbt1 F1 P1 w/Bending Template / - Sterile, Rapid Resorbable Fixation System on 2 May 2016. The recall is Class II and its status is Terminated. Recall number Z-1920-2016.
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 # 851.691.01S, Lot # 6123191, 6913455, 7540885
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 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.
More recalls from Synthes (USA) Products
All 164| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 4 Volt(tm) Tap Cortex Screw To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 4 Volt Tap Locking Screw Tap To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| 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 |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |