Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect
Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (loose device and debris) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Howmedica Osteonics Corp. is recalling 4,895 units of the Stryker Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile. The recall involves specific lot numbers including J4895V, V9556J, and RA3188, among others. The product is identified by Catalog # 504-02-66F-L and UDI (01)07613327012491(17).
The recall was initiated because the Stryker Restoration Anatomic Shell may fall off its post within its inner packaging. This defect can result in the device being loose in the package with coating debris. The agency has classified this as a Class II recall.
The affected devices were distributed worldwide, including in numerous U.S. states such as New York, Texas, California, and Florida. Healthcare providers and facilities that have received these specific lots should stop using the devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 4,895
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #s J4895V
- V9556J
- RA3188
- DH4RW8
- WH083M
- KY10DV
- 937YAE
- XJ1WW1
- K52EHL
- JX5291
- M50LV5
- 561RR3
- 847AX0
- V3377L
- EJ40D2
- W40V6T
- TD3H2L
- 9X0DHT
- LL7R18
- 9N0LH6
Distribution
Part of a larger recall action
This product is one of 16 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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