Reported May 18, 2022 · Ongoing
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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.
- Lot codes and dates
31 of 31 products
Products covered by this recall Model / number Barcodes Product as published 03.405.000S10886982300829Radial Head Replacement Instr Kit 09.405.250S10886982300614Rad Head w/Head 22 shaft 5.5 HH10 +0 09.405.253S10886982300621Rad Head w/Head 22 shaft 5.5 HH10 +3 09.405.256S10886982300638Rad Head w/Head 22 shaft 5.5 HH10 +6 09.405.260S10886982300645Rad Head w/Head 22 shaft 6.5 HH10 +0 09.405.263S10886982300652Rad Head w/Head 22 shaft 6.5 HH10 +3 09.405.266S10886982300669Rad Head w/Head 22 shaft 6.5 HH10 +6 09.405.270S10886982300676Rad Head w/Head 22 shaft 7.5 HH10 +0 09.405.273S10886982300683Rad Head w/Head 22 shaft 7.5 HH10 +3 09.405.276S10886982300690Rad Head w/Head 22 shaft 7.5 HH10 +6 09.405.280S10886982300706Rad Head w/Head 22 shaft 8.5 HH10 +0 09.405.283S10886982300713Rad Head w/Head 22 shaft 8.5 HH10 +3 09.405.286S10886982300720Rad Head w/Head 22 shaft 8.5 HH10 +6 09.405.560S10886982300737Rad Head w/Head 25 shaft 6.5 HH11 +0 09.405.563S10886982300744Rad Head w/Head 25 shaft 6.5 HH11 +3 09.405.566S10886982300751Rad Head w/Head 25 shaft 6.5 HH11 +6 09.405.570S10886982300768Rad Head w/Head 25 shaft 7.5 HH11 +0 09.405.573S10886982300775Rad Head w/Head 25 shaft 7.5 HH11 +3 09.405.576S10886982300782Rad Head w/Head 25 shaft 7.5 HH11 +6 09.405.580S10886982300799Rad Head w/Head 25 shaft 8.5 HH11 +0 - Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
This product could cause temporary or reversible health problems — stop using it.
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