CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report
Radial Head Replacement System Implant is a one-piece recalled
Synthes (USA) Products is recalling Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement, distributed nationwide in the US. The recall was initiated on 7 Apr 2022 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-1072-2022
- FDA event ID
- 89972
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2022
- FDA classified
- 12 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2022 | Recall initiated by company | |
| 12 May 2022 | Classified by FDA | +35 days |
| 18 May 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Product as listed by the FDA
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Which lots are affected?
All serial numbers. Material GTIN Product 03.405.000S 10886982300829 Radial Head Replacement Instr Kit; 09.405.250S 10886982300614 Rad Head w/Head 22 shaft 5.5 HH10 +0; 09.405.253S 10886982300621 Rad Head w/Head 22 shaft 5.5 HH10 +3; 09.405.256S 10886982300638 Rad Head w/Head 22 shaft 5.5 HH10 +6; 09.405.260S 10886982300645 Rad Head w/Head 22 shaft 6.5 HH10 +0; 09.405.263S 10886982300652 Rad Head w/Head 22 shaft 6.5 HH10 +3; 09.405.266S 10886982300669 Rad Head w/Head 22 shaft 6.5 HH10 +6; 09.405.270S 10886982300676 Rad Head w/Head 22 shaft 7.5 HH10 +0; 09.405.273S 10886982300683 Rad Head w/Head 22 shaft 7.5 HH10 +3; 09.405.276S 10886982300690 Rad Head w/Head 22 shaft 7.5 HH10 +6; 09.405.280S 10886982300706 Rad Head w/Head 22 shaft 8.5 HH10 +0; 09.405.283S 10886982300713 Rad Head w/Head 22 shaft 8.5 HH10 +3; 09.405.286S 10886982300720 Rad Head w/Head 22 shaft 8.5 HH10 +6; 09.405.560S 10886982300737 Rad Head w/Head 25 shaft 6.5 HH11 +0; 09.405.563S 10886982300744 Rad Head w/Head 25 shaft 6.5 HH11 +3; 09.405.566S 10886982300751 Rad Head w/Head 25 shaft 6.5 HH11 +6; 09.405.570S 10886982300768 Rad Head w/Head 25 shaft 7.5 HH11 +0; 09.405.573S 10886982300775 Rad Head w/Head 25 shaft 7.5 HH11 +3; 09.405.576S 10886982300782 Rad Head w/Head 25 shaft 7.5 HH11 +6; 09.405.580S 10886982300799 Rad Head w/Head 25 shaft 8.5 HH11 +0; 09.405.583S 10886982300805 Rad Head w/Head 25 shaft 8.5 HH11 +3; 09.405.586S 10886982300812 Rad Head w/Head 25 shaft 8.5 HH11 +6; 09.405.950S 10886982300522 Rad Head w/Head 19 shaft 5.5 HH9 +0; 09.405.953S 10886982300539 Rad Head w/Head 19 shaft 5.5 HH9 +3; 09.405.956S 10886982300546 Rad Head w/Head 19 shaft 5.5 HH9 +6; 09.405.960S 10886982300553 Rad Head w/Head 19 shaft 6.5 HH9 +0; 09.405.963S 10886982300560 Rad Head w/Head 19 shaft 6.5 HH9 +3; 09.405.966S 10886982300577 Rad Head w/Head 19 shaft 6.5 HH9 +6; 09.405.970S 10886982300584 Rad Head w/Head 19 shaft 7.5 HH9 +0; 09.405.973S 10886982300591 Rad Head w/Head 19 shaft 7.5 HH9 +3; 09.405.976S 10886982300607 Rad Head w/Head 19 shaft 7.5 HH9 +6.
Where was it sold?
US Nationwide distribution.
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.
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