Device recalls

SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515

Howmedica Osteonics Corp. · Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impa…

Open, ClassifiedNonconforming Material/ComponentZ-0873-2024
Open FDA's page for this record
Cfres ID
205133
Product res number
Z-0873-2024
Event date initiated
2023-12-01
Event date posted
2024-01-31
Recall status
Open, Classified
Res event number
93687
Product code
JWH
Product description
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Code info
GTIN: 07613327034042 Lot Numbers: WK4PX0
Firm FEI number
3003070421
Recalling firm
Howmedica Osteonics Corp.
Address 1
325 Corporate Dr
City
Mahwah
State
NJ
Postal code
07430-2006
Additional info contact
Loriann Russo 201-831-5000
Root cause description
Nonconforming Material/Component
Reason for recall

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

Action

Stryker issued Urgent Medical Device Recall Letter (Product Field Action #: 3306872)through third party Sedgwick via UPS on 12/1/23. Letter states reason for recall, health risk and action to take: Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected product in Part/Lot Number Attachment: PFA 3306872 starting on page 3. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho4367@sedgwick.com 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 3306872; Please include Tracking information on the package. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com

Distribution pattern

Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

K numbers
K884398
Harmonized identifiers (openFDA)
Device name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty description
Orthopedic
Regulation number
888.3560
Device class
2
K number
K131019, K954138, K983835, K894937, K983004, K062274, K930554, K971550, K932776, K220737, K101994, K140555, K244039, K963255, K980925, K230537, K103117, K915132, K873197, K021740, K222380, K925072, K162222, K030686, K203447, K143047, K020383, K032606, K193105, K910992, K180159, K893762, K023788, K202429, K011643, K021451, K090705, K053579, K152169, K012348 +882 more
Registration number
3006563559, 3009923578, 8010379, 3011061242, 3008985661, 3009590742, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 3003639920, 1450662, 2528981, 9610612, 2133928, 1000200989, 3004513872, 3005551626, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000286794, 1825034, 3008868758, 3010163695, 2249697, 3033509898, 1424263, 3007420745, 2245304, 1220477, 3012523063, 3008102042, 3009173317, 3005360851, 3048147961, 1832228 +282 more
FEI number
3002807036, 3006563559, 3009923578, 3011061242, 3008985661, 3009590742, 1000086912, 3009971621, 3042508254, 3010009693, 3012392319, 3008421730, 1000221916, 3003639920, 1450662, 2528981, 3002287318, 1000200989, 3004513872, 3010938185, 3005551626, 3000717902, 3000717687, 3002806534, 3030412764, 3027484613, 3010123256, 3002808022, 3015516266, 1000136269, 1000286794, 3003574398, 1825034, 3008868758, 3010163695, 3033509898, 3007420745, 2245304, 1220477, 3012523063 +282 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.