DEPUY (IRELAND) recalls Depuy Synthes
Reason for recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410. 2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412. 3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414. 4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416. 5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B; Part Number: 151730418. 6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B; Part Number: 151730420. 7. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 22mm B; Part Number: 151730422. 8. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 24mm B; Part Number: 151730424. 9. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 26mm B; Part Number: 151730426. 10. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 8mm B; Part Number: 151730408. 11. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 10mm C; Part Number: 151730510. 12. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 12mm C; Part Number: 151730512. 13. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 14mm C; Part Number: 151730514. 14. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 16mm C; Part Number: 151730516. 15. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 18mm C; Part Number: 151730518. 16. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 20mm C; Part Number: 151730520. 17. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 22mm C; Part Number: 151730522. 18. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 24mm C; Part Number: 151730524. 19. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 26mm C; Part Number: 151730526. 20. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 8mm C; Part Number: 151730508. 21. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 10mm E; Part Number: 151730710. 22. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 12mm E; Part Number: 151730712. 23. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 14mm E; Part Number: 151730714. 24. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 16mm E; Part Number: 151730716. 25. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 18mm E; Part Number: 151730718. 26. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 20mm E; Part Number: 151730720. 27. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 22mm E; Part Number: 151730722. 28. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 24mm E; Part Number: 151730724. 29. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 26mm E; Part Number: 151730726. 30. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 8mm E; Part Number: 151730708. 31. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 10mm W; Part Number: 151730810. 32. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 12mm W; Part Number: 151730812. 33. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 14mm W; Part Number: 151730814. 34. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 16mm W; Part Number: 151730816. 35. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 18mm W; Part Number: 151730818. 36. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 20mm W; Part Number: 151730820. 37. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 22mm W; Part Number: 151730822. 38. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 8mm F; Part Number: 151730808. 39. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 24mm W; Part Number: 151730824. 40. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 26mm W; Part Number: 151730826.
Lot / code information
- Part / Item #
- 151730410
- GTIN
- 10603295529811
- Lot #
- 1007709. 2
- Part / Item #
- 151730412
- GTIN
- 10603295529828
- Lot #
- 1007710. 3
- Part / Item #
- 151730414
- GTIN
- 10603295529835
- Lot #
- 1005246. 4
- Part / Item #
- 151730416
- GTIN
- 10603295529842
- Lot #
- 1005247, AF1007712. 5
- Part / Item #
- 151730418
- GTIN
- 10603295529859
- Lot #
- 1005248. 6
- Part / Item #
- 151730420
- GTIN
- 10603295529866
- Lot #
- AF1008744. 7
- Part / Item #
- 151730422
- GTIN
- 10603295529873
- Lot #
- 1007308, AF1007715. 8
- Part / Item #
- 151730424
- GTIN
- 10603295529880
- Lot #
- 1005251. 9
- Part / Item #
- 151730426
- GTIN
- 10603295529897
- Lot #
- 1007309, AF1009254. 10
- Part / Item #
- 151730408
- GTIN
- 10603295529903
- Lot #
- 1005243. 11
- Part / Item #
- 151730510
- GTIN
- 10603295529910
- Lot #
- 1008482. 12
- Part / Item #
- 151730512
- GTIN
- 10603295529927
- Lot #
- AF1008370. 13
- Part / Item #
- 151730514
- GTIN
- 10603295529934
- Lot #
- AF1008371. 14
- Part / Item #
- 151730516
- GTIN
- 10603295529941
- Lot #
- AF1008372. 15
- Part / Item #
- 151730518
- GTIN
- 10603295529958
- Lot #
- 1007067. 16
- Part / Item #
- 151730520
- GTIN
- 10603295529965
- Lot #
- 1005343, 1008374. 17
- Part / Item #
- 151730522
- GTIN
- 10603295529972
- Lot #
- 1005259. 18
- Part / Item #
- 151730524
- GTIN
- 10603295529989
- Lot #
- 1008376. 19
- Part / Item #
- 151730526
- GTIN
- 10603295529996
- Lot #
- 1005261, AF1008658. 20
- Part / Item #
- 151730508
- GTIN
- 10603295530008
- Lot #
- 1005253. 21
- Part / Item #
- 151730710
- GTIN
- 10603295530015
- Lot #
- AF1008379. 22
- Part / Item #
- 151730712
- GTIN
- 10603295530022
- Lot #
- AF1008714. 23
- Part / Item #
- 151730714
- GTIN
- 10603295530039
- Lot #
- 1005265. 24
- Part / Item #
- 151730716
- GTIN
- 10603295530046
- Lot #
- AF1008720. 25
- Part / Item #
- 151730718
- GTIN
- 10603295530053
- Lot #
- 1005267 26
- Part / Item #
- 151730720
- GTIN
- 10603295530060
- Lot #
- 1005268. 27
- Part / Item #
- 151730722
- GTIN
- 10603295530077
- Lot #
- AF1005625. 28
- Part / Item #
- 151730724
- GTIN
- 10603295530084
- Lot #
- 1005270. 29
- Part / Item #
- 151730726
- GTIN
- 10603295530091
- Lot #
- AF1008385. 30
- Part / Item #
- 151730708
- GTIN
- 10603295530107
- Lot #
- 1005262. 31
- Part / Item #
- 151730810
- GTIN
- 10603295544289
- Lot #
- AF1008387. 32
- Part / Item #
- 151730812
- GTIN
- 10603295544296
- Lot #
- 1005274, 1008388. 33
- Part / Item #
- 151730814
- GTIN
- 10603295544203
- Lot #
- 1007691. 34
- Part / Item #
- 151730816
- GTIN
- 10603295544210
- Lot #
- 1007692. 35
- Part / Item #
- 151730818
- GTIN
- 10603295544227
- Lot #
- 1005277. 36
- Part / Item #
- 151730820
- GTIN
- 10603295544234
- Lot #
- AF1007694. 37
- Part / Item #
- 151730822
- GTIN
- 10603295544241
- Lot #
- 1005279. 38
- Part / Item #
- 151730808
- GTIN
- 10603295544272
- Lot #
- 1005272. 39
- Part / Item #
- 151730824
- GTIN
- 10603295544258
- Lot #
- 1007696. 40
- Part / Item #
- 151730826
- GTIN
- 10603295544265
- Lot #
- 1007697
Show 110 more code fieldsShow fewer
What the firm is doing
DePuy Synthes notified consignees on about 0519/2026 via email. Consignees were instructed to examine inventory and quarantine any affected units on hand, contact the DePuy Sunthes Sales Consultant or customer support to coordinate the return of affected units, complete and return the Business Response Form, forward the notification to anyone in each facility that needs to be informed, and if any of the affected units have been sold or transferred to contact that facility and provide the notification. Consignees were also requested to post a copy of the notification in a visible area for awareness and keep a copy for your records.
DistributionShow detailsHide
Distribution to MN, NC, TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2617-2026
- FDA 510(k) clearance · K242871The device's official FDA premarket clearance record
- FDA device classification · KROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3510The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find DEPUY (IRELAND)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm